Z-0422-2022 Class II Terminated
FDA device recall Z-0422-2022 was initiated by Biomerieux Inc on Nov 9, 2021 and is designated Class II. 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. The recall status is terminated (terminated Feb 10, 2025). Affected quantity: 1,043 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 5, 2022
- Initiation Date
- Nov 9, 2021
- Termination Date
- Feb 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0422-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026