bioMerieux, Inc. Recall 88797
Description: VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
bioMerieux, Inc. Recall 88797 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0431-2022 |
| Event ID | 88797 |
| Event Description | VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | One lot |
| Recall Reason | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test. |
| Device Classification | 20220105 |
| Device Code Info | UDI 03573026263010, Lot #: 1008861590 |
| Center Classification Date | 20211228 |
| Recall Initiation Date | 20210922 |
| Recalling Firm | bioMerieux, Inc. |
| Initial Notification | |
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