Reported Jan 5, 2022 · Terminated
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Biomerieux Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
- Lot codes and dates
Lot numbers 1008332150Exp. 20-APR-2022and 1008787180Exp. 12-DEC-2022
- Amount recalled
- 1,043 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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