Device product
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Z-1451-2022
Product summary
- Firm
- LumiraDx
- Event
- Event 90479
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 units
- Official record key
device-enforcement:Z-1451-2022
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. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-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.