Recall archive
28 recalls · page 1 of 2
Reported Oct 8, 2025
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used…
FDA (openFDA device enforcement)
Reported Oct 5, 2022
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Invalid calibrations (out of range high) while using the product.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — There are 7 reported software anomalies that may affect use of the device.
FDA (openFDA device enforcement)
Reported Aug 31, 2022
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
FDA (openFDA device enforcement)
Reported May 18, 2022
VITEK 2 Systems and VITEK 2 with MYLA.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jan 5, 2022
VIDAS PRG Progesterone, REF 30409-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand · Reason for recall — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
API 50 CH, Model 50300
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — There is potential to provide an incorrect organism identification.
FDA (openFDA device enforcement)
Reported Apr 29, 2020
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — 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)…
FDA (openFDA device enforcement)
Reported Apr 1, 2020
VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
FDA (openFDA device enforcement)
Reported Feb 19, 2020
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Apr 24, 2019
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand · Product · Product details — Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2…
FDA (openFDA device enforcement)
Reported Feb 27, 2019
VITEK 2 AST-N351 Test Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — False Positive ESBL Phenotype
FDA (openFDA device enforcement)
Reported Dec 26, 2018
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 21, 2018
bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Some eluates become colored because of remaining hemoglobin in the eluate.
FDA (openFDA device enforcement)
Reported Oct 31, 2018
BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2018
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 29, 2018
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General…
High riskUsing this product could cause serious injury, illness or death — stop using it now.bioMerieux, Inc.
Matched: Brand · Product · Product details — Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
FDA (openFDA device enforcement)
Reported Aug 8, 2018
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the…
FDA (openFDA device enforcement)
Reported Jul 18, 2018
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand · Product · Product details — Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2017
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomerieux Inc.
Matched: Brand · Product · Product details — Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association…
FDA (openFDA device enforcement)
Reported Sep 20, 2017
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Some anomalies have been identified during manufacturing controls.
FDA (openFDA device enforcement)
Reported Jul 19, 2017
VIDAS Testosterone, Ref 30418
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when…
FDA (openFDA device enforcement)
Reported Feb 10, 2016
BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2015
MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.bioMerieux, Inc.
Matched: Brand — 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…
6 more products in this recall
FDA (openFDA device enforcement)
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