LumiraDx Recall 90479
Description: LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
LumiraDx Recall 90479 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1451-2022 |
| Event ID | 90479 |
| Event Description | LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control |
| Product Type | Devices |
| Distribution | Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI. |
| Quantity | 99 units |
| Recall Reason | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. |
| Device Classification | 20220727 |
| Device Code Info | No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022). |
| Center Classification Date | 20220721 |
| Recall Initiation Date | 20220624 |
| Recalling Firm | LumiraDx |
| Initial Notification | |
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