BioMerieux SA Recalls
45 recalls on record · April 30, 2014 to October 20, 2021 · Medical Devices
Recalls by year
14
15
16
17
18
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
March 29, 2017Medical DevicesFDA
BioMerieux SA recalls ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique
Hazard: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
March 29, 2017Medical DevicesFDA
BioMerieux SA recalls ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique
Hazard: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
March 1, 2017Medical DevicesFDA
BioMerieux SA recalls ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining t
Hazard: Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
February 22, 2017Medical DevicesFDA
BioMerieux SA recalls VIDAS 3 software v. 1.1.4
Hazard: During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
January 25, 2017Medical DevicesFDA
BioMerieux SA recalls NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended
Hazard: A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
January 25, 2017Medical DevicesFDA
BioMerieux SA recalls MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic
Hazard: A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
August 17, 2016Medical DevicesFDA
BioMerieux SA recalls NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used wit
Hazard: Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
February 10, 2016Medical DevicesFDA
BioMerieux SA recalls API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some mi
Hazard: Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.
July 8, 2015Medical DevicesFDA
BioMerieux SA recalls Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Hazard: QC results were out of range resulting in false resistant strains.
August 20, 2014Medical DevicesFDA
BioMerieux SA recalls VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzy
Hazard: Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.
August 13, 2014Medical DevicesFDA
BioMerieux SA recalls VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in
Hazard: Product is not approved or authorized for distribution in the US.
April 30, 2014Medical DevicesFDA
BioMerieux SA recalls API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). A
Hazard: bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
April 30, 2014Medical DevicesFDA
BioMerieux SA recalls API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of
Hazard: bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
April 30, 2014Medical DevicesFDA
BioMerieux SA recalls FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemi
Hazard: bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
April 30, 2014Medical DevicesFDA
BioMerieux SA recalls ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized bi
Hazard: bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent