FDA Device recall Z-0875-2023
PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR 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-0875-2023 |
| 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
PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
Reason
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Identifiers
| code_info | UDI/DI 03573026320706, Batch Numbers: 1009497920 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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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-0875-2023%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.