FDA Device recall Z-0422-2022
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD
- FDA Device
- Class II
- terminated
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD by Biomerieux, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0422-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-09 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
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.
Identifiers
| code_info | Lot numbers 1008332150, Exp. 20-APR-2022, and 1008787180, Exp. 12-DEC-2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0422-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.