Remel Inc Recall 89416
Description: Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Remel Inc Recall 89416 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0722-2022 |
| Event ID | 89416 |
| Event Description | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format |
| Product Type | Devices |
| Distribution | Distribution throughout the United States. |
| Quantity | 1210 devices |
| Recall Reason | There are lower than expected MICs for some gram negative species. |
| Device Classification | 20220316 |
| Device Code Info | Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16) |
| Center Classification Date | 20220304 |
| Recall Initiation Date | 20220110 |
| Recalling Firm | Remel Inc |
| Initial Notification | Letter |
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