Manufacturer

BioMerieux SA

45 recalls in our database name BioMerieux SA as the manufacturing or recalling firm.

What the numbers show

Total: 45
Critical: 0
Severe: 0
Most recent: 2021-10-20

Of the 45 recalls from BioMerieux SA we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–45 of 45

ModerateFDA (Devices)·Z-1532-2017·2017-03-29
BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Ceftriaxone strips because their shelf-life claims are not supported by internal testing. The products were distributed worldwide.
Product
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1529-2017·2017-03-29
BioMerieux Recalls ETEST Imipenem IP32 Foam Packaging Due to Stability Issues
BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging because the current shelf-life claims are not supported by internal testing.
Product
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entero
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1525-2017·2017-03-29
BioMerieux Recalls ETEST Vancomycin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Vancomycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1521-2017·2017-03-29
BioMerieux Recalls ETEST Ceftazidime Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Ceftazidime TZ256 strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus an
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1524-2017·2017-03-29
BioMerieux Recalls ETEST Ciprofloxacin CI 32 Foam Due to Stability Issues
BioMerieux SA is recalling ETEST Ciprofloxacin CI 32 Foam products because their shelf-life claims are not supported by internal testing.
Product
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1530-2017·2017-03-29
BioMerieux Recalls ETEST Gentamicin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Gentamicin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1531-2017·2017-03-29
BioMerieux Recalls ETEST Tobramycin Strips Due to Stability Issues
BioMerieux SA is recalling ETEST Tobramycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.
Product
ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1226-2017·2017-03-01
BioMerieux ETEST XM256 Cefuroxime Recalled for Potential Performance Issues
BioMerieux SA is recalling ETEST XM256 (Cefuroxime) antimicrobial susceptibility test strips due to potential performance issues that may result in false susceptibility or intermediate results.
Product
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus sp
Category
Medical Device
Distribution
37 states
ModerateFDA (Devices)·Z-1200-2017·2017-02-22
BioMerieux Recalls VIDAS 3 Software Version 1.1.4 Due to Anomalies
BioMerieux SA is recalling 1,161 units of VIDAS 3 software version 1.1.4 in the U.S. because anomalies identified during the development of version 1.2 were found to be present in the current field version.
Product
VIDAS 3 software v. 1.1.4
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0977-2017·2017-01-25
BioMerieux NucliSENS magnetic extraction reagents recalled for performance drift
BioMerieux SA is recalling NucliSENS magnetic extraction reagents because a performance drift was observed in BK virus testing for certain silica batches.
Product
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0976-2017·2017-01-25
BioMerieux Recalls MagSIL Magnetic Silica Reagents Due to Performance Drift
BioMerieux SA is recalling 3,723 units of MagSIL (NucliSENS easyMAG Magnetic Silica) worldwide due to observed performance drift in BK virus testing.
Product
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2342-2016·2016-08-17
BioMerieux Recalls NucliSENS easyMAG Magnetic Silica Reagents
BioMerieux is recalling NucliSENS easyMAG Magnetic Silica reagents due to customer complaints about amplification performance issues.
Product
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0756-2016·2016-02-10
BioMerieux Recalls API ZYM Bx2 Reagent Due to False Negative Results
BioMerieux SA is recalling API ZYM Bx2 reagent because it produces false negative results, leading to discrepant identification outcomes in laboratory tests.
Product
API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1947-2015·2015-07-08
BioMerieux Etest Cefotaxime CT 256 In Vitro Diagnostic Recall
BioMerieux SA is recalling Etest Cefotaxime CT 256 in vitro diagnostic devices because quality control results were out of range, potentially causing false resistant strain results.
Product
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2014·2014-08-20
BioMerieux Recalls VIDAS D-Dimer Exclusion II Test Kits
BioMerieux SA is recalling 2,160 units of VIDAS D-Dimer Exclusion II tests due to complaints of non-repeatable results that may cause false negatives.
Product
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction w
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-2152-2014·2014-08-13
BioMerieux VIDAS TPSA Diagnostic Recalled for Unauthorized Distribution
BioMerieux SA is recalling 1,902 units of VIDAS TPSA in vitro diagnostic tests because the product is not approved or authorized for distribution in the US.
Product
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1476-2014·2014-04-30
BioMerieux Recalls FB Reagent Due to False Negative Test Results
BioMerieux SA is recalling FB Reagent (REF 70562) and ZYM B reagent (REF 70493) because a visual defect and activity issue can cause false negative results in Rapid ID 32 and API biochemical tests.
Product
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and Rapid ID 32 strips. The API and ID 32 strips product lines are a standardized system combining several biochemical tests, which
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2014·2014-04-30
BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results
BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue caused false negative results in Rapid ID 32 strips and API biochemical tests.
Product
API Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1477-2014·2014-04-30
BioMerieux Recalls ZYM B and FB Reagents Due to False Negative Results
BioMerieux is recalling ZYM B and FB reagents because a visual defect and activity issue can cause false negative results in Rapid ID 32 strips and API biochemical tests.
Product
API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1475-2014·2014-04-30
BioMerieux Recalls ZYM B Reagent Due to Visual Defect and Activity Issue
BioMerieux SA is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in microbiological tests.
Product
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species ide
Category
Medical Device
Distribution
Distributed nationwide