Recall record at a glance
| Official record | Z-2671-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | bioMerieux, Inc. |
| Report date | Oct 8, 2025 |
| Recall initiation date | Jun 26, 2025 |
| Quantity | 235269 cards |
| Location | Durham, NC, United States |
Official product description
VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. 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. Export only
Why the product was recalled
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Distribution information
International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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