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Recall Observatory FDA recall evidence

Device 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

Z-0937-2021

December 11, 2020

Class II

Product summary

Firm
Qiagen Sciences LLC
Event
Event 87047
Status
Terminated
Classification
Class II
Quantity
575 kits US
Official record key
device-enforcement:Z-0937-2021

Official wording

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.

Code information: All lots

Distribution pattern: CA, IN, MI, MN, NC, NJ, NM, OH, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.