Lower riskMedical device recall · FDA · Published August 13, 2018
BioMérieux VITEK 2 AST-P655 Recall: Drug Deficiency Risk
BioMérieux recalls VITEK 2 AST-P655 test cards with insufficient gentamicin due to manufacturing error. Affected lots may produce inaccurate test results for bacterial susceptibility.
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
Take action
Contact the company
📍Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
✎ GovInfoNow plain-language explainer
BioMérieux is recalling specific lots of VITEK 2 AST-P655 bacterial test cards because they contain less gentamicin than required. This could lead to inaccurate test results for certain bacteria, potentially affecting medical treatment decisions. Read more at govinfonow.com/recall/70042-biom-rieux-vitek-2-ast-p655-recall-drug-deficiency-risk.
“BioMérieux VITEK 2 AST-P655 Recall: Drug Deficiency Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70042-biom-rieux-vitek-2-ast-p655-recall-drug-deficiency-risk. Based on FDA recall #Z-3180-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3180-2018%22&limit=1).
The FDA announced on Aug. 13, 2018, that BioMérieux voluntarily recalled VITEK(R) 2 AST-P655 cards due to insufficient gentamicin levels. This manufacturing error may lead to inaccurate susceptibility test results for Staphylococcus spp., Enterococcus spp., and S. agalactiae.
How to tell if you have it
Brand: BioMérieux
Product: VITEK(R) 2 AST-P655
REF: 421913
Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403
The hazard
Routine internal review identified that six card lots were manufactured with less gentamicin than required for the Gentamicin High-Level Resistance screen test. The error occurred during the preparation of 1500mL and 2000mL media well solutions.
Context
GovInfoNow's records show Biomerieux Inc has issued 36 other recalls since July 12, 2017. Recent BioMérieux recalls include the VITEK 2 AST-N461 Test Kit recall on July 24, 2026, and the VITEK 2 AST-N447 Kit Recall on June 4, 2026. Other recent recalls of similar products include the HardyDisk AST Cefiderocol 30μg FDC30 recall (June 8, 2026) and the Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
Check if your VITEK 2 AST-P655 test cards have lot numbers 8050348103, 8050452403, 8050655403, or 8050690403. These cards were sold for bacterial susceptibility testing in laboratories.
Brand
BioMérieux
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,
Recall number
Product, codes & lots
Quantity
Z-3179-2018
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.; Lot Numbers: 7400410103, 7400697403
2538 cartons
Z-3180-2018
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth-based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.; Lot Numbers: 8050348103, 8050452403, 8050655403, 8050690403
10919 cartons
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Verify if your VITEK 2 AST-P655 test cards have the affected lot numbers: 8050348103, 8050452403, 8050655403, or 8050690403.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution US Nationwide and the countries of: Turkey, Austria, Switzerland, Czech Republic, Germany, Netherlands,” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 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-3180-2018 (August 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3180-2018 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.