Biomerieux recalls specific VITEK 2 AST test kits (AST-N334, AST-GN95, etc.) due to potential false susceptible results for certain bacteria. Affected kits may mislead antibiotic treatment decisions.
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.
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📍Recalling firmBiomerieux Inc595 Anglum Rd · Hazelwood, MO 63042-2320
✎ GovInfoNow plain-language explainer
Biomerieux is recalling specific VITEK 2 AST test kits that could produce false susceptible results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions. This recall affects laboratory test kits used to determine antimicrobial susceptibility. Read more at govinfonow.com/recall/55879-biomerieux-vitek-2-ast-test-kits-recall-false-susceptible-results.
“Biomerieux VITEK 2 AST Test Kits Recall: False Susceptible Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55879-biomerieux-vitek-2-ast-test-kits-recall-false-susceptible-results. Based on FDA recall #Z-1464-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1464-2024%22&limit=1).
The FDA announced on March 14, 2024, that Biomerieux Inc is recalling VITEK 2 - AST Test kits due to ceftriaxone concentration errors that may cause false susceptible results. The agency issued recall number Z-1464-2024 for the in vitro diagnostic test cards distributed worldwide.
How to tell if you have it
Brand: Biomerieux
Product: VITEK 2 - AST Test kits
AST-N334, REF 418984
AST-GN95, REF 421982
AST-GN99, REF 423102
AST-N390, REF 423340
AST-N391, REF 423341
AST-N392, REF 423342
AST-N395, REF 423491
AST-N401, REF 423643
AST-N402, REF 423644
AST-N404, REF 423664
AST-N802, REF 423706
AST-N405, REF 423864
AST-N417, REF 423880
AST-N408, REF 423924
AST-N409, REF 423925
AST-N420, REF 424039
AST-N423, REF 424042
AST-N422, REF 424056
AST-N436, REF 424440
AST-N809, REF 424703
AST-N806, REF 424709
AST-N807, REF 424710
AST-N808, REF 424711
AST-N810, REF 424712
AST-N812, REF 424721
The hazard
According to the FDA, ceftriaxone concentration errors in specific recently manufactured test kits have the potential for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Context
GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Other recent recalls of similar products include BioFire Joint Infection Panel Recall (April 22, 2026), BioFire Respiratory Panel 2.1 Recall (Oct. 22, 2025), and HardyDisk AST Cefiderocol 30μg FDC30 recall (June 8, 2026).
How to tell if you have this one
Check if your VITEK 2 AST test kit has the model numbers listed (AST-N334, AST-GN95, AST-GN99, etc.) and the specific lot/serial numbers provided in the recall notice.
Brand
Biomerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Review the model number and lot/serial numbers on your VITEK 2 AST test kit to determine if it is affected by this recall.
How this recall unfolded
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-1464-2024 (March 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1464-2024 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.