Z-0941-2021Class II

SARS-CoV-2 Antigen Test

Name: Z-0941-2021 SARS-CoV-2 Antigen Test
Creator: Qiagen Sciences LLC
Published: 2021-01-15
License: https://open.fda.gov/license/

Qiagen / initiated 2021-01-15 / Terminated

FDA source

Qiagen Sciences LLC began a recall of SARS-CoV-2 Antigen Test on 2021-01-15. FDA classified it as Class II and gives the reason as "QIAGEN has become aware of the potential for false positive results to occur with some patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0941-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-15
Posted: 2021-02-01
Terminated: 2022-07-11
Recalling firm: Qiagen
Product: SARS-CoV-2 Antigen Test
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
FDA 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 in commerce: 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
Product codes and lots: GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0941-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0941-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-01-31

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)