Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITEK 2 Gram Negative test kits containing colistin (cs01n) Recalled by Biomerieux Inc Due to The investigation demonstrated a high rate of very...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomerieux Inc directly.
Affected Products
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Quantity: 1,520,000 cards
Why Was This Recalled?
The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).
Where Was This Sold?
This product was distributed to 1 state: NC
About Biomerieux Inc
Biomerieux Inc has 368 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report