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U.S. Department of Health and Human Services

Class 2 Device Recall EZ1 DSP Virus Kit

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  Class 2 Device Recall EZ1 DSP Virus Kit see related information
Date Initiated by Firm May 28, 2018
Create Date August 02, 2018
Recall Status1 Terminated 3 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
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 2		 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.
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