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 | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. |
| Product | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a |
| Quantity | 445 units |
| Distribution | US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX. |
| Initiated | 2025-03-12 |
| Classified | 2025-03-31 |
| Recall number | Z-1504-2025 |
| 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-1504-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96521/
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