Class 2 Device Recall therascreen PIK3CA RGQ PCR Kit

• Date Initiated by Firm: December 11, 2020
• Create Date: January 29, 2021
• Recall Status: Terminated on April 22, 2022
• Recall Number: Z-0937-2021
• Recall Event ID: 87047
• PMA Number: P190001 P190004
• Product Classification: Somatic gene mutation detection system - Product Code OWD
• 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
• Code Information: All lots
• Recalling Firm/ Manufacturer: Qiagen Sciences LLC; 19300 Germantown Rd; Germantown MD 20874-1415
• For Additional Information Contact: SAME; 240-686-7500
• Manufacturer 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.
• FDA Determined 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 mutations including Q546R are detected, disregard the Q546R result only. Continue to consider all other results as valid and report them accordingly. l For the purpose of run validity, Q546R control data must still be produced. The therascreen PIK3CA RGQ PCR Kit software requires valid run control data from the Q546R reaction for the overall test to be valid. Therefore, continue to use all supplied reagents and perform testing as described in the kit handbook, but disregard Q546R positive results generated for patient samples as described in the previous bullet points. l Forward this information to all individuals and departments within your organization who are using the therascreen PIK3CA RGQ PCR Kit REF 873121. If you are not the end-user, please forward this notice to the product end-user. l Review this notice with your laboratory/medical director. l Complete the Acknowledgement or Receipt Form attached to this letter by December 22, 2020 and email it to quality.communications@qiagen.com. QIAGEN is now revising the Instructions for Use for the therascreen PIK3CA RGQ PCR Kit, as described in this notice, to reduce any risk resulting from non-specific molecular interactions within the Q546R reaction leading to the generation of Q546R false mutation positive results. QIAGEN is also updating the therascreen PIK3CA FFPE and Plasma Assay Profile software packages to
• Quantity in Commerce: 575 kits US
• Distribution: CA, IN, MI, MN, NC, NJ, NM, OH, TX
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = OWD