Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RAPID 20 E Recalled by Biomerieux Inc Due to There is an error in the new version...
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
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Quantity: 1,043 units
Why Was This Recalled?
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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