Device product
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Z-0422-2022
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 89041
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,043 units
- Official record key
device-enforcement:Z-0422-2022
Official wording
Reason: 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.
Code information: Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022
Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, and WI. There was government distribution but no military distribution.
Derived failure modes
-
Unknown
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.