Lower riskMedical device recall · FDA · Published March 29, 2022
BioMérieux VITEK 2 Systems Recall: Incorrect Test Results Risk
BioMérieux recalls VITEK 2 Systems and VITEK 2 with MYLA due to software issues causing incorrect antibiotic screen and synergy test results in lab systems. Affected units include specific versions.
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.
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Contact the company
📍Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
“BioMérieux VITEK 2 Systems Recall: Incorrect Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60882-biom-rieux-vitek-2-systems-recall-incorrect-test-results-risk. Based on FDA recall #Z-1059-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1059-2022%22&limit=1).
The FDA announced on March 29, 2022, that bioMerieux, Inc. is recalling VITEK 2 Systems and VITEK 2 with MYLA due to a software issue that may result in incorrect test results sent to laboratory information systems.
How to tell if you have it
Brand: BioMérieux
Product: VITEK 2 Systems (Versions 8.01, 9.01, 9.02 with or without 9MR2; 9.03 with or without #9MR2)
Product: VITEK 2 with MYLA (Versions 4.8 and 4.9)
Units affected: 21,757 systems
The hazard
According to the FDA, a software issue causes results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests to exclude user-corrected or AES-corrected interpretations. This error can potentially lead to incorrect final screen/synergy test results at the LIS.
Context
GovInfoNow's records show Biomerieux Inc has issued 36 other recalls since July 12, 2017. Recent brand recalls include false resistant results risks associated with VITEK 2 AST-N461 Test Kits on July 24, 2026, and VITEK 2 AST-N447 Kits on June 4, 2026. Other recent recalls of similar products include Vivoo Vaginal pH Test Recall (Nov. 22, 2025), Vivoo Protein Test Recall (Nov. 22, 2025), and Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026).
How to tell if you have this one
Check if your VITEK 2 System or VITEK 2 with MYLA has software versions 8.01, 9.01, 9.02, 9.03 (with or without 9MR2), or 4.8/4.9. These versions were sold between 2019 and 2020.
Brand
BioMérieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your VITEK 2 System or VITEK 2 with MYLA software version to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in North Carolina, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: North Carolina.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1059-2022 (March 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1059-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.