bioMerieux, Inc. Recall 89568
Description: VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
bioMerieux, Inc. Recall 89568 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0742-2022 |
| Event ID | 89568 |
| Event Description | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. |
| Product Type | Devices |
| Distribution | Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution. |
| Quantity | 480 kits |
| Recall Reason | Invalid calibrations (out of range high) while using the product. |
| Device Classification | 20221005 |
| Device Code Info | Lot numbers 1008873260, exp. 01JUN2022. |
| Center Classification Date | 20220314 |
| Recall Initiation Date | 20220209 |
| Recalling Firm | bioMerieux, Inc. |
| Initial Notification | Letter |
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