FDA Device recall Z-0825-2023
ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 by Biomerieux, citing as the temperature and time out of range was exceeded, product performances cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0825-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-09 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
Reason
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Identifiers
| code_info | UDI/DI 03573026377953, Batch Numbers: 1009371780 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Biomerieux
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FDA Device · Class II · 2026-09-30 · Biomerieux - VITEK 2 AST-N447 TEST KIT Product reference 424620
FDA Device · Class II · 2026-07-15 · Biomerieux - VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01…
FDA Device · Class II · 2026-02-11 · Biomerieux - VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n
FDA Device · Class II · 2025-10-08 · Biomerieux - VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984
FDA Device · Class I · 2024-05-01 · Biomerieux
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0825-2023%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.