Remel Inc Recall 91104
Description: Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Remel Inc Recall 91104 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0334-2023 |
| Event ID | 91104 |
| Event Description | Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 2656 units |
| Recall 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. |
| Device Classification | 20221214 |
| Device Code Info | Lot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027 |
| Center Classification Date | 20221207 |
| Recall Initiation Date | 20221020 |
| Recalling Firm | Remel Inc |
| Initial Notification | Letter |
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