BioMerieux SA
Complete recall history across all FDA and CPSC categories — 45 total recalls
BioMerieux SA appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (45)
FDA medical device enforcement actions by BioMerieux SA
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 2, 2021 | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System | Under certain conditions, there is a risk for a false negative result. | Class II |
| Jun 22, 2021 | MYLA software. Used to manage microbiology test workflow from the reception ... | Software anomaly - Under certain conditions, unwanted alterations to results ... | Class II |
| Sep 17, 2018 | NucliSENS¿ Magnetic Extraction Reagents | Data loggers showed that one shipment to the United States experienced low te... | Class II |
| Apr 9, 2018 | VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux S... | Invalid calibration with low calibrator S1 while using the product. | Class II |
| Mar 23, 2018 | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to ... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | Oxidase Reagent (ref: 55635): This test is used to detect the production of t... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VI... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for us... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | The VITEK 2 Gram-Positive identification card (GP) is intended for use with t... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS ... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intend... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Mar 23, 2018 | The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exce... | Class II |
| Oct 18, 2017 | NucliSENS Lysis Buffer Extended lot for RES 76675 | Elute may become colored due to the residual presence of heme group originati... | Class II |
| Apr 25, 2017 | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a qu... | False susceptible results | Class II |
| Apr 13, 2017 | ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative techn... | QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST O... | Class II |
| Apr 13, 2017 | ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative tec... | QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST O... | Class II |
| Mar 17, 2017 | VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) as... | Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may caus... | Class II |
| Mar 7, 2017 | NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be ... | Problem with colored eluates for whole blood extractions | Class II |
| Jan 18, 2017 | ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is... | Potential performance issues. False Susceptible result instead of Intermedia... | Class II |
| Jan 11, 2017 | VIDAS 3 software v. 1.1.4 | During development of the VIDAS 3 software version 1.2, some anomalies have b... | Class II |
| Jan 1, 2017 | Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 50705... | Potential performance issue on strain categorization. | Class II |
| Dec 15, 2016 | ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(lo... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32.... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM ... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.01... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenic... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.00... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.01... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.0... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Dec 15, 2016 | ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.00... | Product Stability issues: The current shelf-life claims of the ETEST product... | Class II |
| Nov 23, 2016 | MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS... | A drift of the performance with the BK test (BK virus, worst case application... | Class I |
| Nov 23, 2016 | NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Prod... | A drift of the performance with the BK test (BK virus, worst case application... | Class I |
| Jul 8, 2016 | NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products... | Several customer complaints about amplification performance issues when using... | Class I |
| Jan 8, 2016 | API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional tes... | Discrepant identification results related to API identification strips. Thes... | Class II |
| Jun 12, 2015 | Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic. | QC results were out of range resulting in false resistant strains. | Class II |
| Mar 6, 2014 | API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent... | Class II |
| Mar 6, 2014 | FB Reagent (REF 70562). FB reagent is an additional test used for revealin... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent... | Class II |
| Mar 6, 2014 | API Listeria (REF 10300). ZYM B reagent is used and included inside of API... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent... | Class II |
| Mar 6, 2014 | ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to... | bioMerieux identified a visual defect and activity issue on the ZYM B reagent... | Class II |
| Oct 14, 2013 | VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measure... | Product is not approved or authorized for distribution in the US. | Class II |
| Apr 17, 2013 | VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instrum... | Customer complaints about not repeatable results below the detection limit (<... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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