Device product
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Z-0428-2021
Product summary
- Event
- Event 86550
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,628 kits
- Official record key
device-enforcement:Z-0428-2021
Official wording
Reason: Due to false positive results.
Code information: Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817
Distribution pattern: U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY
Derived failure modes
-
Unknown
Due to false positive results.