Data / Medical devices / France / Biomerieux SA
Biomerieux SA: FDA-registered device maker in MARCY L ETOILE Rhone, France, 26 510(k) clearances
Biomerieux SA is registered with the FDA (registration 8020790) in MARCY L ETOILE Rhone, France. It lists 31 device types. The FDA files 26 510(k) clearances under its listings, the newest dated May 1, 2024. 25 recall events name it as the recalling firm (3 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8020790
- FEI number
- 1000611339
- Address
- Chemin De L Orme, MARCY L ETOILE Rhone, France, 69280
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 26, 1999
- Registered through
- 2027
- Brand names listed
- (TSH), APIWeb, Dry Blood Spot Puncher, ENZYME LINKED IMMUNOA, Free Diluent, MYLA, PREVI FLUO TB, PreviISOLA and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2024 | K240279 | VIDAS TBI (GFAP, UCH-L1) | QAT | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 8, 2022 | K210793 | VIDAS NEPHROCHECK | PIG | Substantially Equivalent | Biomérieux SA | accessdata.fda.gov |
| February 23, 2017 | K162827 | VIDAS B.R.A.H.M.S. PCT (PCT) | PRI | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 28, 2016 | K160911 | VIDAS B.R.A.H.M.S. PCT (PCT) | PMT | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 9, 2013 | K132010 | VIDAS C DIFFICILE GDH | MCB | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| June 4, 2013 | K122979 | VIDAS LYME IGM | LSR | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| March 5, 2013 | K122986 | VIDAS LYME IGG | LSR | Substantially Equivalent | Biomerieux S.A. | accessdata.fda.gov |
| July 31, 2012 | K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) | DAP | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 18, 2011 | K101946 | VIDAS TOXO IGG AVIDITY | LGD | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 23, 2008 | K080766 | VIDAS RUB IGG | LFX | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 11, 2008 | K080931 | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY | LLH | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 11, 2007 | K071146 | VIDAS B.R.A.H.M.S. PCT ASSAY | NTM | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 4, 2000 | K001460 | VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 | LYR | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 22, 2000 | K993319 | VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 | LGD | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 9, 1997 | K965084 | VIDAS PROESTERONE (PRG) (30 409) | JLS | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 6, 1996 | K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | CHP | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| August 2, 1994 | K933549 | VIDAS CMV IGM ASSAY | LKQ | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| August 9, 1993 | K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | LJY | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| July 27, 1993 | K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | JFT | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| February 25, 1993 | K923166 | VIDAS TOXOPLASMA GONDII IGM ASSSAY | LGD | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| February 12, 1993 | K920661 | VIDAS CMV IGG ASSAY | LFZ | Substantially Equivalent | Vitek Systems, Inc. | accessdata.fda.gov |
| October 26, 1992 | K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | LFY | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| July 28, 1992 | K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | JHI | Substantially Equivalent | Vitek Systems, Inc. | accessdata.fda.gov |
| June 18, 1992 | K921816 | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY | JLW | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| June 16, 1992 | K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | CGJ | Substantially Equivalent | Biomerieux Vitek, Inc. | accessdata.fda.gov |
| April 8, 1992 | K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | CEP | Substantially Equivalent | Vitek Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 11, 2026 | 99931 | Not yet classified | Open, Classified | EMAG system Model/Catalog Number: 418591/418591U Product Description: Nucleic acid sample preparation instrument IVD, automated | Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2 | accessdata.fda.gov |
| June 22, 2021 | 87985 | Class II | Terminated | MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. | Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. | accessdata.fda.gov |
| September 17, 2018 | 81067 | Class II | Terminated | NucliSENS Magnetic Extraction Reagents | Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product. | accessdata.fda.gov |
| April 9, 2018 | 79620 | Class II | Terminated | 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 ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluor | Invalid calibration with low calibrator S1 while using the product. | accessdata.fda.gov |
| March 23, 2018 | 80111 | Class II | Terminated | The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux 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. | accessdata.fda.gov |
| October 18, 2017 | 78387 | Class II | Terminated | NucliSENS Lysis Buffer Extended lot for RES 76675 | 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 inh | accessdata.fda.gov |
| April 25, 2017 | 76983 | Class II | Terminated | ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distr | False susceptible results | accessdata.fda.gov |
| April 13, 2017 | 78688 | Class II | Terminated | ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species. | 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. | accessdata.fda.gov |
| March 17, 2017 | 76727 | Class II | Terminated | VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked | Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant. | accessdata.fda.gov |
| March 7, 2017 | 76675 | Class II | Terminated | NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens | Problem with colored eluates for whole blood extractions | accessdata.fda.gov |
| January 18, 2017 | 76329 | Class II | Terminated | ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobact | Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods. | accessdata.fda.gov |
| January 11, 2017 | 76281 | Class II | Terminated | VIDAS 3 software v. 1.1.4 | During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field. | accessdata.fda.gov |
| January 1, 2017 | 77150 | Class II | Terminated | Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba | Potential performance issue on strain categorization. | accessdata.fda.gov |
| December 15, 2016 | 76201 | Class II | Terminated | ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such a | Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing. | accessdata.fda.gov |
| November 23, 2016 | 76026 | Class I | Terminated | MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS easyMAG system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucle | A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016. | accessdata.fda.gov |
| July 8, 2016 | 74761 | Class I | Terminated | NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the | Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform. | accessdata.fda.gov |
| April 15, 2016 | 73989 | Class III | Terminated | VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human se | Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. | accessdata.fda.gov |
| January 8, 2016 | 73060 | Class II | Terminated | API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips. | Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent. | accessdata.fda.gov |
| November 19, 2015 | 72755 | Class I | Terminated | Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. | Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. | accessdata.fda.gov |
| June 12, 2015 | 71475 | Class II | Terminated | 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. | accessdata.fda.gov |
| October 16, 2014 | 69579 | Class III | Terminated | Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | accessdata.fda.gov |
| March 6, 2014 | 67820 | Class II | Terminated | 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 the API strips. The API product line is a standardized system combining seve | bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent | accessdata.fda.gov |
| November 8, 2013 | 66931 | Class II | Terminated | ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several b | bioMrieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent. | accessdata.fda.gov |
| October 14, 2013 | 68749 | Class II | Terminated | VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma. | Product is not approved or authorized for distribution in the US. | accessdata.fda.gov |
| April 17, 2013 | 68747 | Class II | Terminated | VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluoresce | Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL. | accessdata.fda.gov |
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Updated October 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.