SARS-CoV-2 Antigen Test
Hazard
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
What You Should Do
Remedy
On 01/13/2021, Qiagen issued Urgent Medical Device Correction notices to customers via phone and email. Customers were advised to do the following stop using the product and return any remaining product back to Qiagen.
Affected by this recall?
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Products
SARS-CoV-2 Antigen Test
- Brand
- Qiagen Sciences LLC
- UPC
- GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
Units Affected
1092 boxes of 60 (65,520 e-sticks)