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U.S. Department of Health and Human Services

Class 2 Device Recall Factor II (Prothrombin) G20210A Kit

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  Class 2 Device Recall Factor II (Prothrombin) G20210A 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-2565-2011
Recall Event ID 58747
Product Classification Prothrombin-proconvertin and thrombotest - Product Code JPF
Product Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument;

The Factor II (Prothrombin) G20210A Kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene 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 II DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (Prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A 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 Roche Confidential Page 3 of 9 LightCycler¿ Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.tributed by Roche Diagnostics Indianapolis, IN 46256 USA; 03610195001
Code Information Lot Number Expiration 12658920 30-Sep-2007 13065720 31-Mar-2008 13218920 31-May-2008 13412020 31-Aug-2008 13462320 30-Sep-2008 13560320 31-Oct-2008 13736420 31-Jan-2009 13990720 31-Mar-2009 14066120 31-May-2009 14172820 31-Jul-2009 14172821 31-Jul-2009 14674120 31-Dec-2009 14837220 28-Feb-2010 10963920 30-Sep-2010 11242020 31-Jan-2011 11333523 31-Jan-2011 11509420 30-Apr-2011 11509520 30-Apr-2011 11928321 30-Sep-2011 11928420 30-Sep-2011 12180220 30-Nov-2011 12181020 31-Dec-2011
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 13,864 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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