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U.S. Department of Health and Human Services

Class 2 Device Recall Factor V Leiden Kit;

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  Class 2 Device Recall Factor V Leiden Kit; see related information
Date Initiated by Firm March 31, 2011
Date Posted June 14, 2011
Recall Status1 Terminated 3 on August 13, 2012
Recall Number Z-2566-2011
Recall Event ID 58747
Product Classification Test, factor v leiden mutations, genomic dna pcr - Product Code NPQ
Product Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 03610179001.

For use with Light Cycler 2.0 instrument; The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler¿ 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler¿ 2.0 Instrument using the LightCycler¿ Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.
Code Information Lot Number Expiration 12659020 30-Sep-2007 13014720 31-Jan-2008 13368720 31-Jul-2008 13368820 31-Jul-2008 13462420 30-Sep-2008 13749620 31-Jan-2009 13793120 31-Jan-2009 14066220 31-May-2009 14447220 30-Jun-2009 14172920 30-Sep-2009 14692620 31-Dec-2009 14692621 31-Dec-2009 10964020 30-Sep-2010 11242120 31-Jan-2011 11666730 31-May-2011 11965420 30-Sep-2011 12180320 31-Dec-2011 12433020 30-Apr-2012
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 South
Somerville NJ 08876-3733
For Additional Information Contact Mr. Vincent Stagnitto
908-253-7200
Manufacturer Reason
for Recall		 Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the Factor V Leiden Kit for use with the Light Cycler 2.0 Instrument in the US Market
FDA Determined
Cause 2		 Other
Action Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to discontinue use of the affected product by August 31, 2011. Complete the attached faxback form ( 4293-00-0311 ) and fax it to 1-888-345-5359. For questions or technical support, please contact Roche Molecular at 1-800-526-1247,
Quantity in Commerce 17,026 units
Distribution Nationwide Distribution
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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