Lower riskMedical device recall · FDA · Published October 22, 2018
bioMerieux VITEK 2 AST Products May Give False Resistant Results
bioMerieux recalls VITEK 2 antimicrobial testing products that may show false resistance to Streptococcus anginosus and constellatus strains. Affected items include specific catalog numbers for laboratory use.
“bioMerieux VITEK 2 AST Products May Give False Resistant Results.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69568-biomerieux-vitek-2-ast-products-may-give-false-resistant-results. Based on FDA recall #Z-0618-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0618-2019%22&limit=1).
The FDA announced on 2018-10-22 that bioMerieux, Inc. is recalling VITEK 2 Antimicrobial Susceptibility Testing kits due to the risk of false resistant results for Streptococcus anginosus and Streptococcus constellatus strains.
How to tell if you have it
Catalog # 410028, VITEK 2 AST-ST01
Catalog # 420915, VITEK 2 AST-ST02
Catalog # 421040, VITEK 2 AST-ST03
The hazard
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported. The FDA said the hazard involves potential misidentification of antibiotic susceptibility.
Context
GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since 2017-07-12. Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24), Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04), and Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (2026-01-05). Other recent recalls of similar products include HardyDisk AST Cefiderocol 30μg FDC30 (2026-06-08) and Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (2026-06-26).
How to tell if you have this one
Check for catalog numbers 410028, 420915, or 421040 on the VITEK 2 AST products. These items are used in clinical laboratories for antimicrobial susceptibility testing.
Brand
bioMerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Catalog Numbers
Verify if your VITEK 2 products have catalog numbers 410028, 420915, or 421040.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 12 months 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-0618-2019 (October 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0618-2019 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.