Biomerieux Inc Recall 89041
Description: RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Biomerieux Inc Recall 89041 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0422-2022 |
| Event ID | 89041 |
| Event Description | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 1,043 units |
| Recall 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. |
| Device Classification | 20220105 |
| Device Code Info | Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022 |
| Center Classification Date | 20211227 |
| Recall Initiation Date | 20211109 |
| Recalling Firm | Biomerieux Inc |
| Initial Notification | Letter |
| Similar To |