Thermo SCIENTIFIC — Class I medical device recall Z-0332-2023
Terminated recall by Remel Inc, reported 2022-12-14, distributed nationwide. An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Pla
| Recall number | Z-0332-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2022-10-20 |
| Classified | 2022-12-07 |
| Reported by FDA | 2022-12-14 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,647 units |
| Lot numbers | B1453, B2034, B2151A, B2281 |
Product
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0332-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.