Qiagen Sciences LLC: Medical Device Recall in 2021 - (Recall #: Z-0937-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 11, 2020

Date Posted: February 3, 2021

Recall Number: Z-0937-2021

Event ID: 87047

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.

Status: Terminated

Product Quantity: 575 kits US

Code Information:

All lots

Distribution Pattern:

CA, IN, MI, MN, NC, NJ, NM, OH, TX

Voluntary or Mandated:

Voluntary: Firm initiated