FDA Device recall Z-0937-2021
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment…
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II recall of therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment… by Qiagen Sciences, citing kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0937-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-11 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qiagen Sciences |
| Distribution | CA, IN, MI, MN, NC, NJ, NM, OH, TX |
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
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0937-2021%22
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