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U.S. Department of Health and Human Services

Class 2 Device Recall Qiagen artus CMV RG PCR ASR

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  Class 2 Device Recall Qiagen artus CMV RG PCR ASR see related information
Date Initiated by Firm January 30, 2013
Date Posted May 14, 2013
Recall Status1 Terminated 3 on July 01, 2013
Recall Number Z-1320-2013
Recall Event ID 64650
Product Classification Antibody igm,if, cytomegalovirus virus - Product Code LKQ
Product QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225)

Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.
Code Information Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14
Recalling Firm/
Manufacturer		 QIAGEN Gaithersburg, Inc.
1201 Clopper Rd
Gaithersburg MD 20878-4000
For Additional Information Contact Donna Sowers
301-944-7284
Manufacturer Reason
for Recall		 CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Qiagen Gaithersburg, Inc. issued a PRODUCT FIELD ACTION letter dated February 4, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the vials prior to use to ensure that the vials are labeled "CMV RG Master" Vials labeled "EBV TM Master" should NOT be used and count the vials and discard per internal laboratory procedures. Qiagen will replace free of charge or credit any kits discovered with incorrect master mix vials. Please complete page 2 of this notice as soon as possible and email or fax it back to us at: (661) 702-3854, techservice-na@qiagen.com. If you have additional questions or concerns polease do not hestiate to call QIAGEN Technical Services at 1-800-344-3631 option 2 or by e-mail techservice-na@qiagen.com.
Quantity in Commerce 90 kits in total
Distribution USA Nationwide Distribution including the states of: CA, DC, FL, GA, MA, MD, MI, and IL.
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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