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 | Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use. |
| Product | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121 |
| Quantity | 575 kits US |
| Distribution | CA, IN, MI, MN, NC, NJ, NM, OH, TX |
| Initiated | 2020-12-11 |
| Classified | 2021-01-28 |
| Terminated | 2022-04-22 |
| Recall number | Z-0937-2021 |
| 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-0937-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87047/
Alerts for QIAGEN Sciences LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.