Z-0422-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- November 9, 2021
- Termination Date
- February 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,043 units
Product Description
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Reason for Recall
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.
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.
Code Information
Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022