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-1650-2022
• Recall Event ID: 90691
• PMA Number: P180043
• Product Classification: Somatic gene mutation detection system - Product Code OWD
• Product: therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
• Code Information: Lot number: 172017274 Exp Date: 10.11.2022 169046366 Exp. Date: 12.06.2022
• 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: 22 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