Class 2 Device Recall Therascreen EGFR RGQ PCR Kit

• Date Initiated by Firm: April 08, 2020
• Create Date: June 05, 2020
• Recall Status: Terminated on June 03, 2021
• Recall Number: Z-2290-2020
• Recall Event ID: 85565
• PMA Number: P120022
• Product Classification: Digestive enzyme adipose cell and adipose tissue preparation apparatus for banking and cryopreservation - Product Code OWG
• Product: therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
• Code Information: All lots
• Recalling Firm/ Manufacturer: Qiagen Sciences LLC; 19300 Germantown Rd; Germantown MD 20874-1415
• For Additional Information Contact: 800-362-7737
• Manufacturer Reason for Recall: There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Correction notification letters dated 4/8/20 were sent to customers. Actions to be taken by the customer: For continued use of the therascreen EGFR RGQ PCR Kit (24), check the delta CT values (¿CT) in the sample result table for automated interpretation of results. For mutation positive results with a ¿CT below -10.00, these should be considered invalid and retested. To implement the new cutoff for the delta CT (¿CT), the following new instruction replaces the Table 12 (p.46) of the therascreen EGFR RGQ PCR Kit Handbook. ¿ If you have concerns about previously generated mutation positive results with the therascreen EGFR RGQ PCR Kit (24), REF. 870121, the criteria listed above can be used for review. ¿ The mixing step described in the DNA sample assessment protocol (page 25, step 8) of the therascreen EGFR RGQ PCR Handbook dated October 2019 should also be performed after step 10 on page 36 of the mutation detection protocol. ¿ To obtain a valid qPCR result for the controls and samples, strict attention must be paid to thorough reagent mixing at each mixing step during the assay setup in accordance to the instructions for use. ¿ Forward this information to all individuals and departments within your organization who are using the therascreen EGFR RGQ PCR Kit (24), REF. 870121. 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 April 24, 2020 and email it to quality.communications@qiagen.com. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com Actions taken by QIAGEN QIAGEN is revising the instructions for use as described in this notice to reduce any risk resulting from fluorescence artefacts leading to invalid runs or fals
• Quantity in Commerce: 530 kits within expiry
• Distribution: US Nationwide.

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.