Events

Recall of Device Recall Factor II (Prothrombin) G20210A Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Molecular Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58747
  • Event Risk Class
    Class 2
  • Event Number
    Z-2565-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100215
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prothrombin-proconvertin and thrombotest - Product Code JPF
  • Reason
    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.
  • 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,

Device

Device Recall Factor II (Prothrombin) G20210A Kit
  • Model / Serial
    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 Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 US Highway 202 South, Somerville NJ 08876-3733
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA