Biomerieux Inc recalls VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Biomerieux recalls VITEK 2 AST-N461 test kits with potential false resistant results, risking ineffective antibiotic treatments. Affected lots produced between specific dates.
Lower-risk recall
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 antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
What happened, in plain English
Biomerieux is recalling VITEK 2 AST-N461 test kits that could give false resistant results. This might lead to less effective antibiotics or harmful side effects, potentially affecting patient health. Read more at govinfonow.com/recall/1292729-biomerieux-vitek-2-ast-n461-test-kit-recall-false-resistant.
Source Summary by GovInfoNow · govinfonow.com/recall/1292729-biomerieux-vitek-2-ast-n461-test-kit-recall-false-resistant · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3231-2026
Cite this page
“Biomerieux VITEK 2 AST-N461 Test Kit Recall: False Resistant Results Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292729-biomerieux-vitek-2-ast-n461-test-kit-recall-false-resistant. Based on FDA recall #Z-3231-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3231-2026%22&limit=1).
Why it’s dangerous
The test kits could have damaged card pouches from a specific production run, causing false results. False resistant results might lead to using less effective antibiotics or combining multiple antibiotics with negative side effects, which could impact patient health.
Who’s affected
Laboratory users who own or use the VITEK 2 AST-N461 test kits with the specific lot number 1333393504 are most at risk. Healthcare professionals using these kits for gram-negative susceptibility testing may be affected.
How to tell if you have this one
Check for the lot number 1333393504 on the VITEK 2 AST-N461 test kits. The kits were produced using a specific card pouching device during a specific timeframe.
- Brand
Biomerieux- Category
Medical device
What to do — step by step
Check Kit Lot Number
Look for the lot number 1333393504 on the VITEK 2 AST-N461 test kits.
Questions people ask
What is the specific problem with these test kits?
The card pouches in some of these kits could be damaged, causing false resistant results that might lead to less effective antibiotics or harmful side effects.
How can I tell if I have the affected kits?
Check for the lot number 1333393504 on the VITEK 2 AST-N461 test kits.
What should I do if I have the affected kits?
The recall record does not specify a remedy, so contact Biomerieux for guidance.
Contact Biomerieux
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-3231-2026 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-3231-2026 from Biomerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
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-3231-2026 (July 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3231-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.