Z-2565-2011

Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular...

Name: Z-2565-2011 Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular...
Creator: Roche Molecular Systems, Inc.
Published: 2011-03-31
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2011-03-31 / Terminated

FDA source

Roche Molecular Systems, Inc. began a recall of Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with... on 2011-03-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2565-2011
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-06-14
Terminated: 2012-08-13
Recalling firm: Roche Molecular Systems Inc
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
Product code: JPF Prothrombin-Proconvertin And Thrombotest
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 root cause: 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
Product codes and lots: 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

Product code JPF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)