FDA Device recall Z-0332-2023
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
- FDA Device
- Class I
- terminated
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class I recall of Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST by Remel, citing an internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0332-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-10-20 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Remel |
| Distribution | US |
Product
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
Reason
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Identifiers
| code_info | Lot Numbers: B2281, B2151A, B2034, B1453 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Remel
- GC Agar Base (150mm) 10/PK R04030
FDA Device · Class II · 2026-07-08 · Remel - Yeastone Broth, 11ML, 10/BOX YY3462
FDA Device · Class II · 2026-04-22 · Remel - Campy CVA Medium 100/PK, R01272
FDA Device · Class II · 2026-03-04 · Remel - 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
FDA Device · Class II · 2025-12-03 · Remel - Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Device · Class II · 2025-08-06 · Remel
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0332-2023%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.