U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The spetzler claw tip was packaged with the incorrect tip sleeve assembly. the tip sleeve assembly included in the packaging is the incorrect size.
risk to health:
if the tip sleeve assembly does not fit the spetzler claw" tip, a surgical delay may occur while an alternate tip sleeve assembly is retrieved.
Action
On 3/22/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments:
Kara Spath
269-389-4518
kara.spath@stryker.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The affected devices may contain a dimensional deviation that could potentially result in the
surgeon being unable to seat the polyethylene (pe) insert on the affected vks tibial base
plate during surgery.
Action
The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock.
If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the somatom emotion or somatom sensation systems in conjunction with the use of the cardio licenses "cardio pro" and "cardio retro".
Action
A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the somatom emotion or somatom sensation systems in conjunction with the use of the cardio licenses "cardio pro" and "cardio retro".
Action
A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the somatom emotion or somatom sensation systems in conjunction with the use of the cardio licenses "cardio pro" and "cardio retro".
Action
A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the somatom emotion or somatom sensation systems in conjunction with the use of the cardio licenses "cardio pro" and "cardio retro".
Action
A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the somatom emotion or somatom sensation systems in conjunction with the use of the cardio licenses "cardio pro" and "cardio retro".
Action
A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the somatom emotion or somatom sensation systems in conjunction with the use of the cardio licenses "cardio pro" and "cardio retro".
Action
A Safety Advisory Notice was sent to customers informing them of a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems. Siemens informed them that they will deliver an Update Instruction for their Service Engineers to modify the installed Firmware. This will correct the rare synchronization errors of Scanner Firmware and Scanner Software to start the application of the x-ray in compliance with the optimum triggering point for best image quality.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Susceptibility test cards, antimicrobial - Product Code LTW
Cause
Product insert fails to identify performance limitation related to eucast breakpoints for teicolplanin.
Action
Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Susceptibility test cards, antimicrobial - Product Code LTW
Cause
Product insert fails to identify performance limitation related to eucast breakpoints for teicolplanin.
Action
Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Susceptibility test cards, antimicrobial - Product Code LTW
Cause
Product insert fails to identify performance limitation related to eucast breakpoints for teicolplanin.
Action
Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Susceptibility test cards, antimicrobial - Product Code LTW
Cause
Product insert fails to identify performance limitation related to eucast breakpoints for teicolplanin.
Action
Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.