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All Recalls

Every Biomerieux Sa Recall

Sorted by most recent. Click any recall for full details.

24 recalls
High RiskFDA
Biomerieux Sa
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Medical Devices·542 affected·Sep 2, 2021
High RiskFDA
Biomerieux Sa
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, ...
Medical Devices·248 affected·Jun 22, 2021
High RiskFDA
Biomerieux Sa
NucliSENS¿ Magnetic Extraction Reagents
Diagnostic Devices·42 affected·Sep 17, 2018
High RiskFDA
Biomerieux Sa
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family...
Diagnostic Devices·59 affected·Apr 9, 2018
High RiskFDA
Biomerieux Sa
The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test ...
Medical Devices·5 affected·Mar 23, 2018
High RiskFDA
Biomerieux Sa
The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated ident...
Diagnostic Devices·135 affected·Mar 23, 2018
High RiskFDA
Biomerieux Sa
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma...
Diagnostic Devices·2 affected·Mar 23, 2018
High RiskFDA
Biomerieux Sa
The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most ...
Diagnostic Devices·15 affected·Mar 23, 2018
High RiskFDA
Biomerieux Sa
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susce...
Medical Devices·3,238 affected·Apr 25, 2017
High RiskFDA
Biomerieux Sa
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of b...
Diagnostic Devices·1,585 affected·Apr 13, 2017
High RiskFDA
Biomerieux Sa
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial ...
Medical Devices·7,160 affected·Jan 18, 2017
High RiskFDA
Biomerieux Sa
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determin...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining t...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining ...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determini...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining ...
Medical Devices·0 affected·Dec 15, 2016
CriticalFDA
Biomerieux Sa
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for th...
Diagnostic Devices·3,723 affected·Nov 23, 2016
CriticalFDA
Biomerieux Sa
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device a...
Diagnostic Devices·3,723 affected·Nov 23, 2016
High RiskFDA
Biomerieux Sa
ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test in...
Diagnostic Devices·33,853 affected·Mar 6, 2014
High RiskFDA
Biomerieux Sa
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 a...
Diagnostic Devices·33,853 affected·Mar 6, 2014
High RiskFDA
Biomerieux Sa
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included...
Diagnostic Devices·33,853 affected·Mar 6, 2014
High RiskFDA
Biomerieux Sa
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determinati...
Diagnostic Devices·2,160 affected·Apr 17, 2013