BioMerieux SA Recalls
45 recalls on record · April 30, 2014 to October 20, 2021 · Medical Devices
Recalls by year
14
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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:
October 20, 2021Medical DevicesFDA
BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Hazard: Under certain conditions, there is a risk for a false negative result.
August 18, 2021Medical DevicesFDA
BioMerieux SA recalls MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results
Hazard: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
October 31, 2018Medical DevicesFDA
BioMerieux SA recalls NucliSENS¿ Magnetic Extraction Reagents
Hazard: Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
July 4, 2018Medical DevicesFDA
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
Hazard: Invalid calibration with low calibrator S1 while using the product.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. T
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examinati
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms f
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination o
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as a
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for th
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automate
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
June 20, 2018Medical DevicesFDA
BioMerieux SA recalls The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identi
Hazard: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
December 27, 2017Medical DevicesFDA
BioMerieux SA recalls ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susc
Hazard: QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
December 27, 2017Medical DevicesFDA
BioMerieux SA recalls ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial su
Hazard: QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
November 15, 2017Medical DevicesFDA
BioMerieux SA recalls NucliSENS Lysis Buffer Extended lot for RES 76675
Hazard: Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.
May 31, 2017Medical DevicesFDA
BioMerieux SA recalls Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique fo
Hazard: Potential performance issue on strain categorization.
May 24, 2017Medical DevicesFDA
BioMerieux SA recalls ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the an
Hazard: False susceptible results
April 19, 2017Medical DevicesFDA
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
Hazard: Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
April 12, 2017Medical DevicesFDA
BioMerieux SA recalls NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid f
Hazard: Problem with colored eluates for whole blood extractions
March 29, 2017Medical DevicesFDA
BioMerieux SA recalls ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative techn
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 Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative techni
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 Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative techni
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 Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for det
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 Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative techni
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 Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quan
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 Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique fo
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 Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 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 Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique fo
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¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for
Hazard: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.