Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott hematology has identified the following issues with the alinity hq analyzer:
(1) lab temperatures exceeding 220 celsius (c) may cause false positive or elevated nucleated red blood cell (nrbc) counts and corresponding falsely decreased white blood cell (wbc) counts.
(2) mean cell volume (mcv) may be biased for mcv values above approximately 105 femtoliters (fl) and below approximately 70 fl.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Alinity ci‐series software version 2.5.0 (list number 04v20‐03) contained changes to how the alinity i processing module handled process path movement issues. after installing this new software version, customers have reported an increase in the occurrence of message code 5752: "process path move error on (0) lane. 0 = process path lane." when this message code occurs, all tests are sent to exception. recovery from the error requires the operator to initiate or resume sample processing on the alinity i processing module. the increase in the message code 5752 is due to a less effective auto‐recovery procedure contained in software version 2.5.0.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott has identified that architect shbg results generated with the potassium edta specimen tube type may demonstrate a negative shift relative to results generated with serum. shbg dimer destabilization in edta could result in low shbg measurements by immunoassay. all in‐date lots of current reagent inventory are impacted.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott has identified that the incorrect components, 2 assay diluent bottles (6c18j) or 2 pretreatment bottles (6c18x), may be present in a portion of batch 90059fn00.
kits that do not contain all correct components cannot be scanned on the architect instrument, an error code will be generated upon loading on the reagent inventory screen (eg: error code 0900 or 0201).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott diagnostics is recalling clinical chemistry urea nitrogen reagent due to particulate matter in some reagent cartridges.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott has identified a stability issue that may lead to controls out of range. the calibrator lot may not be able to be used due to this issue.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The purpose of this letter is to inform you of a product recall for the alinity c creatine kinase (ck)
reagent lot number listed above and to provide instructions on what actions your laboratory
must take.
abbott has identified a product stability issue that may lead to the following:
message code 1041 “unable to calculate result. reaction check failure.”
quality control (qc) results out of range low.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott has identified the following issues with the alinity ci‐series: 1. after a failure of the reagent 2 (r2) pipettor, the software fails to send scheduled tests that were aspirated after the failure to exceptions. 2. results, reported in alternate result units, that are greater than the linearity incorrectly displays the numerical result value in the default units, for assays using the spline or logit‐4 data reduction method. 3. the host connection is disabled after 12 seconds when no order is received, even though the configured host query time‐out has not been exceeded. 4. an unexpected software shutdown can occur when printing the assay parameter report when the thousand/decimal separator number format is set to the period and comma option. patient impact refer to appendix a for details concerning any patient or safety impact related to the issues identified in alinity ci‐series system software version 2.00.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott has developed alinity s system software v2.0 (ln 04u76‐07) to address known issues and enhance the overall alinity s system (ln 06p16‐01).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The purpose of this letter is to inform you of a product recall for the architect creatine kinase
(ck) reagent lot numbers listed above and to provide instructions on what actions your
laboratory must take.
abbott has identified a stability issue that may lead to the following issues:
error code 1054 “unable to calculate result, reaction check failure”
quality control (qc) results out of range low.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott diagnostics is recalling alkaline wash lot number 49059un14 due to leaking product and/or material received with loose bottle caps that may have leaked during shipment.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott hematology has become aware that the cell‐dyn ruby instrument at your facility has a printed circuit board assembly (pcba) that may prematurely fail and result in the loss of vacuum/pressure.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott has identified that the incorrect components, 2 assay diluent bottles (7k61j) or 2 pretreatment 1 bottles (7k61u), may be present in a portion of batch 91345ui00.
kits that do not contain all correct components cannot be scanned on the architect instrument, an error code will be generated upon loading on the reagent inventory screen (eg: error code 0900 or 0201).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Samples tested using alinity i free t3 and alinity i total t3 assays may show depressed results due to reagent carryover when testing on board with the alinity i 25‐oh vitamin d (ln 08p45).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Alinity s system software v2.1.O is now available and will resolve the following issues that abbott has identified.
1- when the alinity s cmv igg qualitative assay is run as the last assay on a sample, the instrument may shut down. if the instrument does not shut down, the result is an insufficient wash of the probe. the insufficient wash may compromise the following
sample aspirated with that probe, potentially causing a false reactive result for any of the assays run.
2-during sample processing, exceptions that have completed transmission to the laboratory information system (lis) or middleware may continue to appear on the alinity s exception details screen as pending transmission.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Some bcm sccs with part number 01l67-003 or 01l67-004 have a shortage of ram. to make sure that every bcm has the correct memory configuration, this tsb provides instructions to inspect the quantity of ram on sccs and install additional ram if needed.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott hematology has identified the following issue with alinity hq analyzer software version 1.0 and 2.0 when creating an open tube test order via the system command center (scc) or through the abbott middleware system (ams):
for open‐tube processing only, the system will default to “unspecified” gender (instead of using male or female) and apply the limits that the user may have established for the “unspecified” gender type. if the user did not establish limits, there will not be annotations/flags for the “unspecified” gender type, as the system defaults to the factory‐established limits.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The lipase reagent package insert for the lots above has incorrect information regarding the required cuvette smartwash for triglyceride.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott determined that 17% of the two reagent lots listed in this fsn may exhibit lower relative light units (rlus) than expected, which in turn may result in controls out of range or patient results higher than expected.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The cell-dyn ruby allows the display of parameter results in usa, international system of
units (si), modified international system of units (si mod), unit set 1 or unit set 2 per user
configuration. abbott has identified the following issue related to unit set selection for celldyn
ruby analyzers using system software versions 2.2ml and lower:
standard deviation (sd) values for select parameters (refer to table a) in the qc views
only (qc-qcid data view and qc-levey jennings) will be incorrectly displayed when unit
sets other than the usa unit are selected on the cell-dyn ruby. these units are
incorrectly converted from usa units to other unit sets for display purposes.
means, percent cv, and limit (upper and lower) information in qc views are correct. in
addition, instrument flagging, alerts, and results are correct for all unit sets.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Usage of either axsym free t4 standard calibrator or control n their own may have resulted in an observation of controls out of range. using them both together may have resulted in a valid calibration and depressed patient results may have been observed.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott has observed cases in which the outflow graft bend relief (ogbr) on the heartmate 3 (hm3) left ventricular assist system (lvas) was not fully and evenly secured to the outflow graft.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Abbott is advising you that we have received reports where damage to the cable that connects the motor to the console resulted in interruption of active support.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Cause
1. a small number of precision xceedpro blood glucose test strips lots produce control solution results out of range and higher than expected percentage coefficient of variation and standard deviation with controls. this issue does not affect patient blood glucose or β-ketone results, as confirmed through the manufacturer internal testing of retained strips and performance monitoring program.
2. precision xceedpro monitors with serial numbers beginning with “kc” do not fully support a subset of the following barcode types: interleaved 2 of 5 (i 2 of 5), code 128 and code 39. as stated in label copy, if you cannot scan a barcode using the barcode scanner, the data entry keypad on your precision xceedpro monitor allows you to manually enter identification numbers and letters.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug 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 Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
At extremely high blood glucose levels of 1024 mg/dl and above, the freestyle insulinx meter will display and store in memory an incorrect test result that is 1024 mg/dl below the measured result.