FDA Device recall Z-2226-2021
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of ETEST IMIPENEM RELEBACTAM. in vitro diagnostic by Biomerieux, citing major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2226-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-24 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Reason
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Identifiers
| code_info | Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350…Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580 |
|---|
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-2226-2021%22
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