Qiagen Sciences LLC SARS-CoV-2 Antigen Test Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SARS-CoV-2 Antigen Test
Brand
Qiagen Sciences LLC
Lot Codes / Batch Numbers
GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
Products Sold
GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
Qiagen Sciences LLC is recalling SARS-CoV-2 Antigen Test due to QIAGEN has become aware of the potential for false positive results to occur with some patient samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, FL, HI, IL, KY, MI, MO, NJ, NM, NY, NC, OH, RI, TX, WA, WY, DC
Page updated: Jan 10, 2026