Recall Z-0937-2021— Qiagen Sciences LLC
Class II · Terminated
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2020-12-11, terminated 2022-04-22. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-11
- Terminated
- 2022-04-22
- Firm location
- Germantown, MD, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.