therascreen PIK3CA RGQ PCR Kit — Class II medical device recall Z-0937-2021
Terminated recall by Qiagen Sciences LLC, reported 2021-02-03, distributed in CA, IN, MI, MN, NC, NJ, NM, OH…. Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the
| Recall number | Z-0937-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2020-12-11 |
| Classified | 2021-01-28 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2022-04-22 |
| Distributed | CA, IN, MI, MN, NC, NJ, NM, OH, TX |
| Quantity | 575 kits |
| Model numbers | 873121 |
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
Reason for recall
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.
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-0937-2021. 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.