FDA Device recall Z-0941-2021
SARS-CoV-2 Antigen Test
- FDA Device
- Class II
- terminated
- Published 2021-02-10
On 2021-02-10 the FDA classified a Class II recall of SARS-CoV-2 Antigen Test by Qiagen Sciences, citing QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0941-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-15 |
| Published | 2021-02-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qiagen Sciences |
| Distribution | AZ, CA, CO, DC, FL, HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY |
Product
SARS-CoV-2 Antigen Test
Reason
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Identifiers
| code_info | GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0941-2021%22
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