Recall Z-0422-2022 ยท JSS Kit, Identification, Enterobacteriaceae
Biomerieux Inc
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
| Date | Nov 9, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | bioMerieux in the U.S. issued an Urgent Field Safety Notice dated November 2021 on 11/9/2021 via email for delivery to the Lab Director or Lab Manager. The notice described the issue, impact to the customer, and listed the required customer actions: Distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the product may have been transferred. The customer is informed they can continue to use RAPID 20 E, however, they must refer to the following Reading Table or to the correcte |
| Quantity | 1,043 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.