RegWardenFDA facility compliance records
Company

BIOMERIEUX SA

82 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2012: 4 recalls; 2013: 6 recalls; 2014: 3 recalls; 2015: 8 recalls; 2016: 6 recalls; 2017: 15 recalls; 2018: 13 recalls; 2019: 3 recalls; 2020: 4 recalls; 2021: 9 recalls; 2022: 5 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls; 2026: 3 recalls4’126’133’148’156’1615’1713’183’194’209’215’221’231’241’253’26
  • Recalls (82)

Registered facilities (16)

Recalls & enforcement

20263 records
  • Class IIOngoing2026-07-24
    The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibi…
  • Class IIOngoing2026-06-04
    Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
  • Class IIOngoing2026-01-05
    Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant res…
20251 record
  • Class IIOngoing2025-06-26
    Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
20241 record
  • Class IOngoing2024-03-14
    Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
20231 record
  • Class IIOngoing2023-02-06
    For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
20225 records
  • Class IIOngoing2022-11-09
    As the temperature and time out of range was exceeded, product performances cannot be guaranteed
  • Class IIOngoing2022-07-20
    There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
  • Class IIOngoing2022-07-13
    There are 7 reported software anomalies that may affect use of the device.
  • Class IIOngoing2022-03-29
    Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
  • Class IITerminated2022-02-09
    Invalid calibrations (out of range high) while using the product.
20219 records
  • Class IITerminated2021-12-20
    Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
  • Class IITerminated2021-11-09
    There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
  • Class IITerminated2021-09-30
    There is potential to provide an incorrect organism identification.
  • Class IIOngoing2021-09-22
    bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
  • Class IITerminated2021-09-02
    Under certain conditions, there is a risk for a false negative result.
  • Class IITerminated2021-06-24
    Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
  • Class IITerminated2021-06-22
    Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
  • Class IITerminated2021-03-16
    bioMerieux received complaints about calibration issue observed on several lots of VIDAS® CMV IgM (ref 30205 ; 30205-01).
  • Class IITerminated2021-01-28
    bioMrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK® 2 do not match the results sent to the LIS and the Laboratory Technician wou…
20204 records
  • Class IIOngoing2020-03-11
    There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
  • Class IITerminated2020-02-05
    The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
  • Class IITerminated2020-01-24
    The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.
  • Class IITerminated2020-01-10
    Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201. The issue is linked to drift of pH electrode dysfunction.
20193 records
  • Class IITerminated2019-12-10
    Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
  • Class IITerminated2019-10-22
    Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm dis…
  • Class IITerminated2019-03-15
    Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.
201813 records
  • Class IITerminated2018-12-13
    False Positive ESBL Phenotype
  • Class IITerminated2018-11-13
    The VITEK® 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK® 2 FLEXPREP" feature.
  • Class IITerminated2018-10-22
    False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
  • Class IITerminated2018-10-08
    Some eluates become colored because of remaining hemoglobin in the eluate.
  • Class IITerminated2018-09-17
    Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
  • Class IITerminated2018-08-13
    Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparatio…
  • Class IITerminated2018-06-27
    The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards…
  • Class IITerminated2018-04-09
    Invalid calibration with low calibrator S1 while using the product.
  • Class IITerminated2018-03-23
    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 d…
  • Class IITerminated2018-03-01
    Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
  • Class ITerminated2018-01-26
    Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
  • Class IITerminated2018-01-23
    Missing desiccant.
  • Class IITerminated2018-01-04
    Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS® and mini VIDAS® system due to a decrease of pipetted volume.
201715 records
  • Class IITerminated2017-10-18
    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 …
  • Class IITerminated2017-10-11
    Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for t…
  • Class IITerminated2017-08-25
    Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID car…
  • Class IITerminated2017-07-12
    Customers have reported that some VITEK® 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK® 2 Compact 15 and Compact 30 system…
  • Class IITerminated2017-05-16
    The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK® 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method…
  • Class IITerminated2017-05-15
    Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
  • Class IITerminated2017-04-25
    False susceptible results
  • Class IITerminated2017-04-20
    The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
  • Class IITerminated2017-04-13
    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.
  • Class IITerminated2017-04-10
    Some anomalies have been identified during manufacturing controls.
  • Class IITerminated2017-03-17
    Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
  • Class IITerminated2017-03-07
    Problem with colored eluates for whole blood extractions
  • Class IITerminated2017-01-18
    Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
  • Class IITerminated2017-01-11
    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.
  • Class IITerminated2017-01-01
    Potential performance issue on strain categorization.
20166 records
  • Class IITerminated2016-12-15
    Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
  • Class ITerminated2016-11-23
    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.
  • Class ITerminated2016-07-08
    Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
  • Class IITerminated2016-02-24
    Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
  • Class ITerminated2016-02-24
    Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
  • Class IITerminated2016-01-08
    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.
20158 records
  • Class IITerminated2015-12-24
    Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
  • Class IITerminated2015-11-23
    FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
  • Class ITerminated2015-11-19
    Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
  • Class IITerminated2015-11-03
    MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
  • Class IITerminated2015-06-12
    QC results were out of range resulting in false resistant strains.
  • Class IITerminated2015-04-14
    The MYLA® server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in high volume settings. The MYLA server slows down and will stop processing completely if any task requ…
  • Class IITerminated2015-03-27
    The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
  • Class IIITerminated2015-02-25
    The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
20143 records
  • Class IIITerminated2014-10-16
    The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
  • Class IITerminated2014-03-06
    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
  • Class IITerminated2014-02-10
    The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.
20136 records
  • Class IITerminated2013-10-14
    Product is not approved or authorized for distribution in the US.
  • Class IITerminated2013-09-06
    Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.
  • Class IITerminated2013-06-14
    A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated prop…
  • Class IITerminated2013-04-17
    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.
  • Class IITerminated2013-02-18
    There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
  • Class IITerminated2013-02-06
    The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
20124 records

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “BIOMERIEUX SA — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8020790-biomerieux-sa/

Not open yet

Alerts for BIOMERIEUX SA

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.