Class 2 Device Recall Qiagen Therascreen FGFR RGQ RTPCR Kit

• Date Initiated by Firm: July 20, 2022
• Create Date: August 29, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1652-2022
• Recall Event ID: 90691
• PMA Number: P180043
• Product Classification: Somatic gene mutation detection system - Product Code OWD
• Product: FGFR RGQ RT-PCR Kit (RUO, not IVD); REF 8747010
• Code Information: Lot number: 169047135 Exp Date: 12.06.2022 172017806 Exp. Date: 10.11.2022
• 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: Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
• FDA Determined Cause: Under Investigation by firm
• Action: Qiagen issued July 20,2022 letter ( REF 874721) via email (A) US customers: notify customers by Urgent Medical Device Correction Letter; (B) CE customers: notify customers by Urgent Field Safety Notice (C) RUO (not IVD) customers: notify customers by Important Notice. Letter states reason for recall, health risk and action to take: For the continued use of REF 874721 therascreen FGFR RGQ RT-PCR Kit LOT 172017274 , please note the following criteria: ¿ Samples with the Overall sample result No Alteration Detected should be regarded as correct and no further actions are needed. ¿ Samples with the FGFR Alteration Detected results with Individual target result S249C Mutation Detected can be regarded as correct. This also includes samples with additional alterations detected. ¿ All other FGFR Alteration Detected results aside from S249C Mutation Detected should be disregarded and a retest for confirmatory positive result should be performed using the extracted RNA if available, or re-extracted if it is not. ¿ The following results should be assigned to the affected samples after the retest: l Retest result is positive for the same target(s)/ alteration(s): regard the result for the corresponding sample as positive. l Retest result is positive for different target(s)/ alteration(s) in the retest compared to the initial result: regard the result as indeterminate. l Retest is negative: the result for the corresponding sample should be regarded as negative l Retested sample is within an invalid run: repeat the run. l Result for individual sample is invalid in the retest: regard the result as indeterminate Forward this information to all individuals and departments within your organization who are using REF 874721 therascreen FGFR RGQ RT-PCR Kit. l 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 of Receipt Form attached to this letter by 28 July
• Quantity in Commerce: 9 kits
• Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OWD and Original Applicant = QIAGEN GmbH