Class 2 Device Recall EZ1 DSP Virus Kit

• Date Initiated by Firm: May 28, 2018
• Create Date: August 02, 2018
• Recall Status: Terminated on April 05, 2019
• Recall Number: Z-2596-2018
• Recall Event ID: 80430
• Product Classification: Clinical sample concentrator - Product Code JJH
• Product: EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
• Code Information: UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19
• FEI Number: 3013155221
• Recalling Firm/ Manufacturer: QIAGEN; 19300 GERMANTOWN RD; GERMANTOWN MD 20874 USA; KOELN Germany
• Manufacturer Reason for Recall: Underfilled reagent well that could lead to incorrect results
• FDA Determined Cause: Under Investigation by firm
• Action: On May 28, 2018 QIAGEN issued an Urgent Notice of Product Field Action and a Acknowledgement of Receipt form to customers. Actions to be taken by the customer/user/commercial partner are as follows: - If you have any remaining stocks, do not use them, contact our technical service for a free-of-charge replacement and dispose of the product in accordance with your national, local safety and environmental regulations. - Review the notice with your laboratory/medical director. - Forward the information to all individuals and departments within your organization. - If product was further distributed, forward a copy of the notice to the product end user. - QIAGEN also recommends a review of the corresponding results. Consider the possibility of under-quantification and false negative results and evaluate the need for retesting with different EZ1 DSP Virus Kit lots e.g. depending on the clinical presentation and history of the patient - Complete and return the Acknowledgement of Receipt form and email to: quality.communications@qiagen.com.
• Quantity in Commerce: 287 pcs
• Distribution: Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.