Class 2 Device Recall Qiagen

• Date Initiated by Firm: February 25, 2022
• Create Date: April 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0951-2022
• Recall Event ID: 89914
• PMA Number: P110027
• Product Classification: Somatic gene mutation detection system - Product Code OWD
• Product: therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
• Code Information: All lot numbers. GTIN number: 04053228002048
• 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: False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
• FDA Determined Cause: Device Design
• Action: Qiagen issued Urgent Medical Device Correction therascreen KRAS RGQ PCR Kit (24), REF 870021 letter on 2/25/22. Letter states reason for recall, health risk and action to take: This notice is only relevant for the analysis of samples originating from non-small cell lung cancer (NSCLC) tissue. For continued use of the therascreen KRAS RGQ PCR Kit (24), check the Flags/Warnings in the Sample Result table for automated interpretation of results. Sample results with one or more of the Flags/Warnings listed in this notice should be regarded as invalid with respect to the KRAS status and KRAS Mutation status. Setup a new PCR run to repeat the affected sample(s). To minimize Flags/Warnings for the controls and samples, strict compliance to the IFU guidance should be followed, including but not limited to: Correct reagent mixing is required, and must be ensured at each mixing step during the assay setup. Placement of the Rotor-Gene Q MDx according to Installation Procedures site requirements Forward this information to all individuals and departments within your organization who are using the therascreen KRAS RGQ PCR Kit (24), REF. 870021. If you are not the end user, please forward this notice to the product end user. Review this notice with your laboratory/medical director. Complete the Acknowledgement of Receipt Form attached to this letter by March 10, 2022 and email it to quality.communications@qiagen.com. QIAGEN is revising the Instructions for Use, as described in this notice, to reduce any risk resulting from the calling of a false positive or false negative G12C (12CYS) mutation result for NSCLC samples due to the Flags/Warnings listed in this notice and to emphasize strict compliance to the IFU guidance to minimize Flags/Warning. If you have any questions or concerns, pleas.se contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
• Quantity in Commerce: 435 kits
• Distribution: AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV
• 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