FDA Device

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.

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)