BioMerieux SA recalls

39 recalls on record · latest: September 2, 2021

Official U.S. recall history for BioMerieux SA, compiled from official government records.

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BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

September 2, 2021 · Medical device recalls Moderate risk Under certain conditions, there is a risk for a false negative result.

BioMerieux SA recalls MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results…

June 22, 2021 · Medical device recalls Moderate risk Software anomaly - Under certain conditions, unwanted alterations to results co…

BioMerieux SA recalls NucliSENS¿ Magnetic Extraction Reagents

September 17, 2018 · Medical device recalls Moderate risk Data loggers showed that one shipment to the United States experienced low temp…

BioMerieux SA recalls VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of th…

April 9, 2018 · Medical device recalls Moderate risk Invalid calibration with low calibrator S1 while using the product.

BioMerieux SA recalls The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for t…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated ident…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automat…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria.…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examinat…

March 23, 2018 · Medical device recalls Moderate risk A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceed…

BioMerieux SA recalls NucliSENS Lysis Buffer Extended lot for RES 76675

October 18, 2017 · Medical device recalls Moderate risk Elute may become colored due to the residual presence of heme group origination…

BioMerieux SA recalls ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the an…

April 25, 2017 · Medical device recalls Moderate risk False susceptible results

BioMerieux SA recalls ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial suscepti…

April 13, 2017 · Medical device recalls Moderate risk QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX…

BioMerieux SA recalls ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial suscepti…

April 13, 2017 · Medical device recalls Moderate risk QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX…

BioMerieux SA recalls VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments…

March 17, 2017 · Medical device recalls Moderate risk Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause…

BioMerieux SA recalls NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid f…

March 7, 2017 · Medical device recalls Moderate risk Problem with colored eluates for whole blood extractions

BioMerieux SA recalls ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the…

January 18, 2017 · Medical device recalls Moderate risk Potential performance issues. False Susceptible result instead of Intermediate…

BioMerieux SA recalls VIDAS 3 software v. 1.1.4

January 11, 2017 · Medical device recalls Moderate risk During development of the VIDAS 3 software version 1.2, some anomalies have bee…

BioMerieux SA recalls Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for de…

January 1, 2017 · Medical device recalls Moderate risk Potential performance issue on strain categorization.

BioMerieux SA recalls ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative techn…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative techni…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique fo…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quan…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative techni…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative techni…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for det…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for…

December 15, 2016 · Medical device recalls Moderate risk Product Stability issues: The current shelf-life claims of the ETEST products a…

BioMerieux SA recalls NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to b…

November 23, 2016 · Medical device recalls High risk A drift of the performance with the BK test (BK virus, worst case application)…

BioMerieux SA recalls MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic med…

November 23, 2016 · Medical device recalls High risk A drift of the performance with the BK test (BK virus, worst case application)…

BioMerieux SA recalls NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with…

July 8, 2016 · Medical device recalls High risk Several customer complaints about amplification performance issues when using d…

BioMerieux SA recalls API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some minia…

January 8, 2016 · Medical device recalls Moderate risk Discrepant identification results related to API identification strips. These d…

BioMerieux SA recalls Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

June 12, 2015 · Medical device recalls Moderate risk QC results were out of range resulting in false resistant strains.