Class 2 Device Recall QIAamp DSP Virus Kit

• Date Initiated by Firm: July 22, 2017
• Create Date: December 21, 2017
• Recall Status: Terminated on July 26, 2018
• Recall Number: Z-0274-2018
• Recall Event ID: 78646
• Product Classification: unknown device name - Product Code N/A
• Product: QIAamp DSP Virus Kit; Cat. No. 60704
• Code Information: QIAamp DSP Virus Kit, Cat. No. 60704, lot 154025928 , 154027751, 154029053, 154029743 and 154029744.
• Recalling Firm/ Manufacturer: Qiagen, GmbH; Qiagen Str. 1; Hilden Germany
• Manufacturer Reason for Recall: Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Qiagen sent ffected customers and commercial partners "Urgent Notice of Product Field Action", dated June 22, 2017 via an e-mail containing a letter as pdf. In the letter, customers were informed of the reason for recall, with an overview of affected products, detailed description of issue, consequences of the issue, actions to be taken by the customer/user, completion of the acknowledgement of receipt form, contact information and the commercial partners are instructed to forward , actions that have been initiated by AIAGEN, the letter to their customers.
• Quantity in Commerce: 555
• Distribution: AR; AT; BE; CH; CN; CZ; DE; ES; FR; GB; GR; HK; IN; IR, IT; KR; MX; NL; NP, PH; PK; PL; TR, TW; US; UY, VN

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.