Device product
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Z-1450-2022
Product summary
- Firm
- LumiraDx
- Event
- Event 90479
- Status
- Terminated
- Classification
- Class II
- Quantity
- 635 units
- Official record key
device-enforcement:Z-1450-2022
Official wording
Reason: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Code information: No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022).
Distribution pattern: Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Derived failure modes
-
Unknown
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.