SARS-CoV-2 Antigen Test — Class II medical device recall Z-0941-2021
Terminated recall by Qiagen Sciences LLC, reported 2021-02-10, distributed in AZ, CA, CO, DC, FL, HI, IL, KY…. QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
| Recall number | Z-0941-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2021-01-15 |
| Classified | 2021-01-31 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2022-07-11 |
| Distributed | AZ, CA, CO, DC, FL, HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY |
| UPC / GTIN / UDI-DI | 04053228039785 |
| Lot numbers | 86651, 86652, 86653, 86654, 86659 |
| Model numbers | 646533 |
Product
SARS-CoV-2 Antigen Test
Reason for recall
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0941-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.