FDA Medical Device Recalls (openFDA)
Qiagen Sciences LLC: SARS-CoV-2 Antigen Test
- Recall number
- Z-0941-2021
- Recalling firm
- Qiagen Sciences LLC
- Product
- SARS-CoV-2 Antigen Test
- Status
- Terminated
- Initiated
- 2021-01-15
- Posted
- not on file
- Terminated
- 2022-07-11
- Reason
- QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 1092 boxes of 60 (65,520 e-sticks)
- Distribution
- Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
- Lot, serial or model codes
- GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3003572099
- Firm city
- Germantown
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28