Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Identified that the tubing was not fitted correctly to the mask during production. this may result in malfuntioning during use, whereby if the tubing and masks connected bythe user is not firm enough, the tubing may come off during usage.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Customer reported that during processing the tissue was lost. as a result patient required a rebiopsy. (see medsafe ref #14409)., latch on the cassette was broken.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
The dryslide oxidase is used for determining the oxidase reaction of bacteria., during the manufacturing process, portions of the test slides were placed into the incorrect product packaging. this could result in intermittent quality control and false results (the dryslide oxidase is used for determininh the oxidase reaction of bacteria).
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
Cause
Manufacturer's qa program has determined that a reassignment of a customer aceptance range is required for three lots of product. manufacturer received 5 complaints of invalid test runs due to results falling outside the cut-off value customer accetpance range leading to an invalid test. analysis has indicated that the invalid test runs are due to the customer acceptance range being inappropriately assigned for these batches.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: The Business Advisory Group Ltd, Level 13, 34 Shortland St, Auckland 1010
Cause
Recall for product correction for the addition of a safety enhancement called air reduction mitigation (arm). this safety enhancement is being implemented to address the potential risk for air embolism should a donor be prematurely connected to the trimal accel system.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Manufacturer has received a number of complaints relating to blood leakage when the bd vacutainer multile sample luer adapter is used in the blood collection process. these complaints relate to:, 1. the sleeve covering the np cannula, 2.Luer tip damage., due to current stocks holdings both locally and globally and existing demands bd is unable to substitute product for the bd vacutainer multiple sample luer adapter. should a defective device be used bd is providing information (product correction ) regarding the use of the device ., bd recommends that staff closley observe the luer tip of the device for potential damage. in the event that damage is observed staff are instructed to discard the individual device. should blood leak from the luer connection during blood collection ases the need to conduct a re-draw with a new luer adaptor, based upn the volume of blood in the tube.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
Cause
Potential safety issue due to non-unique series identifiers embedded in image headers of certain ge mr products.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Cause
There is a potential for edge of the probe plus ii rotational knob to rub against the tyvek(r) and in remote instances puncture the tyvek(r) creating a pin hole. due to the possibility that a tear in the tyvek(r) packaging may compromise the sterility of the device the stated setrility levels could not be assured for the product. the endopath probe pluss ii shaft is sold and labelled as "sterile".
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
Cause
A customer complaint was received stating that the respond wire diameter description listed on the invoice did not match the descriptor listed on the packaging.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
During beam delivery, the tolerance values are used to do a check for unwanted movements. these values are known as "static tolerances" which are related to all the digital accelerator geometric movement axes except table column. the problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. a fault occurs if the loaded database is incorrect.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
Cause
Manufacturer has identified an anomaly with the rpm respiratory gating system. while operating with the 6-dot marker block, this version of the rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions., the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-door marker block during a calibration sequence, a reference session or a single session after tracking has begun.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
During internal studies it was noted that architect stat high sensitive troponin-i calibrators and controls may decline in performance prior to their defined expiration notes.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
During internal studies it was noted that architect stat high sensitive troponin-i calibrators and controls may decline in performance prior to their defined expiration notes.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
Cause
Manufacturer confirms that it has received complaints from customers of "abnormal reaction" errors occurring on calibrations, qa and patient samples. the abnormal reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation. manufacturer advises that results reported with the abnormal reaction flag are acurate, however per the vista operator's guide, flagged results should not be reported and should be repeated. this is considered no health risk.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Architect toxo igg reagents lots are showing reduced specificity which may cause a shift to higher iu/ml values leading to increased grayzone and/or reactive results. the assay sensitivty is not impacted and current data indicates that no other lots are affected.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Cause
The manufacturer has identified that specific lots of folate calibrators show reduced stability and do not meet the expiration date claims. this can potential result in falsely elevated patient results.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
Cause
The manufacturer has identified that specific lots of folate calibrators show reduced stability and do not meet the expiration date claims. this can potential result in falsely elevated patient results.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Cause
An inclination switch in the stand may have been mounted incorrectly during system service. as a result, the switch could not stop the tilting movement of the table base in the event of a combination of several hardware or software errors.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
Cause
There is the potential for a serious injury if all of the following occurs:, 1/ one of the safety springs breaks and, 2/ u-arm is in the upper or middle position of its movement range when the spring breaks and, 3/ patient or operator is positioned below the u-arm.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Cause
The manufacturer is recalling these devices due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
Notes supplémentaires dans les données
Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
Cause
The manufacturer is recalling these devices due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.