Z-1451-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- June 24, 2022
- Termination Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 units
Product Description
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Reason for Recall
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Distribution Pattern
Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Code Information
No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).