Class II — Qiagen Sciences LLC
| Recalling firm | QIAGEN Sciences LLC |
|---|---|
| Registered facility | QIAGEN (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | QIAGEN has become aware of the potential for false positive results to occur with some patient samples. |
| Product | SARS-CoV-2 Antigen Test |
| 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 |
| Initiated | 2021-01-15 |
| Classified | 2021-01-31 |
| Terminated | 2022-07-11 |
| Recall number | Z-0941-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Qiagen Sciences LLC (Z-0941-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87205/
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