Device product
SARS-CoV-2 Antigen Test
Z-0941-2021
Product summary
- Event
- Event 87205
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1092 boxes of 60 (65,520 e-sticks)
- Official record key
device-enforcement:Z-0941-2021
Official wording
Reason: QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Code information: GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
Distribution pattern: Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
Derived failure modes
-
Unknown
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.