FDA Device recall Z-0329-2023
Thermo SCIENTIFIC, Sensititre GN7F, 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 GN7F, 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-0329-2023 |
| 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 GN7F, 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: B2317, B2267, B2251, B2177, B2086, B2037, B2034B, B1476, B1424, B1384, B1286, B1215, B1182, B1104, B1051, B1021 |
|---|
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-0329-2023%22
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