BioMerieux SA
24 recalls on record · Latest: Oct 20, 2021
FDA Devices Moderate Oct 20, 2021
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
FDA Devices Moderate Aug 18, 2021
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and…
FDA Devices Moderate Oct 31, 2018
NucliSENS¿ Magnetic Extraction Reagents
FDA Devices Moderate Jul 4, 2018
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 (VITEK Immu…
FDA Devices Moderate Jun 20, 2018
The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine…
FDA Devices Moderate Jun 20, 2018
The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of…
FDA Devices Moderate Jun 20, 2018
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity…
FDA Devices Moderate Jun 20, 2018
The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant …
FDA Devices Moderate Dec 27, 2017
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria spec…
FDA Devices Moderate May 24, 2017
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of…
FDA Devices Moderate Mar 29, 2017
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobi…
FDA Devices Moderate Mar 29, 2017
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the anti…
FDA Devices Moderate Mar 29, 2017
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicro…
FDA Devices Moderate Mar 29, 2017
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicr…
FDA Devices Moderate Mar 29, 2017
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antim…
FDA Devices Moderate Mar 29, 2017
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobi…
FDA Devices Moderate Mar 29, 2017
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicr…
FDA Devices Moderate Mar 1, 2017
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibili…
FDA Devices Critical Jan 25, 2017
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction…
FDA Devices Critical Jan 25, 2017
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intend…
FDA Devices Moderate Aug 20, 2014
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin…
FDA Devices Moderate Apr 30, 2014
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 th…
FDA Devices Moderate Apr 30, 2014
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 standardi…
FDA Devices Moderate Apr 30, 2014