Recall Z-0937-2021 ยท OWD Somatic Gene Mutation Detection System
Qiagen Sciences LLC
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
| Date | Dec 11, 2020 |
| 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. |
| Root cause | Process control |
| Action | Qiagen US notified customers by Urgent Medical Device Correction letter via e-mail on 12/11/20. The e-mail additionally contains the letter as PDF. Letter states reason for recall, health risk and action to take: For patient samples where a PIK3CA Mutation Detected Result is obtained, disregard Q546R positive results. Cease to report patient samples where a Q546R mutation result is obtained as PIK3CA Mutation Detected. Information about individual target results is specifically obtained from the Individual target result column of the Rotor-Gene Assay Manager v2.1 result table. If multiple m |
| Quantity | 575 kits US |
| Distribution | CA, IN, MI, MN, NC, NJ, NM, OH, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.