Class II — Qiagen Sciences LLC
| Recalling firm | QIAGEN Sciences LLC |
|---|---|
| Registered facility | QIAGEN (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Faulty cartridges in the lot could result in false test results. |
| Product | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 |
| Quantity | 347 kits |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN. |
| Initiated | 2023-04-28 |
| Classified | 2023-06-02 |
| Recall number | Z-1683-2023 |
| 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-1683-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92298/
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