bioMerieux recalls VITEK 2 Systems Software Version 9.01 Update Kit due to potential incorrect organism identification and antimicrobial susceptibility testing results when using the FLEXPREP feature.
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.
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📍Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
“bioMerieux VITEK 2 Software Update Kit Recall: Incorrect Organism Identification Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69478-biomerieux-vitek-2-software-update-kit-recall-incorrect-organism-identification. Based on FDA recall #Z-0639-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0639-2019%22&limit=1).
The FDA announced on 2018-11-13 that bioMerieux, Inc. is recalling the VITEK¿ 2 Systems Software Version 9.01 Update Kit. The software may display incorrect organism identification and antimicrobial susceptibility testing results when using the VITEK¿ 2 FLEXPREP feature.
How to tell if you have it
Brand: bioMerieux
Product: VITEK¿ 2 Systems Software Version 9.01 Update Kit
Description: KIT UPDT VTK2 9.01 EN
UDI: 03573026561260
The hazard
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.
Context
GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since 2017-07-12. Other recent recalls of similar products include BioFire Joint Infection Panel Recall: False Positives Risk (2026-04-22), Bioporto ProNephro AKI Reagent Kit Recall: Risk of Missed Kidney Disease Diagnosis (2026-05-18), and Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit: Incorrect Algorithms May Affect Test Results (2026-06-26).
How to tell if you have this one
Check if you have the VITEK 2 Systems Software Version 9.01 Update Kit (UDI: 03573026561260). The product was sold by bioMerieux Inc.
Brand
bioMerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your VITEK 2 Systems software version by checking the product label or documentation.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Nationwide distribution to CO, IL, MO, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Illinois, Missouri, Texas.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0639-2019 (November 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0639-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.