Events

Recall of Device Recall FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument

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
    53708
  • Event Risk Class
    Class 2
  • Event Number
    Z1006-2010
  • Event Initiated Date
    2009-03-12
  • Event Date Posted
    2010-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86392
  • 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
    Test, factor ii g202 10a mutations, genomic dna pcr - Product Code NPR
  • Reason
    Within the precautions and warning section, polymorphism heading, of the product's package insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the mutation probe. these rare mutations will lead to an unknown result after performing genotyping.
  • Action
    Product Advisory Notices were sent via e-mail on 3/12/09 to Roche Local Safety Officers and Roche county General Manager. Local Safety Officers and General Managers were to communicate to the end users with the Important Product Notice. In addition, Reagent Bulletin 09-052, dated 3/27/09, was issued to Roche U.S. Affiliate of U.S. customers.

Device

Device Recall FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument
  • Model / Serial
    All lots between 12/18/03 and 4/16/09.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 || Cont. || 1 FIIG20210A MD Mix, 1 x 78 uL || 2. FIIG20210A R mix, 1 x 78 uL || 3. FIIG20210A CT, 1 x 50 uL || 5, FIIG20210A DIL 1 x 1 mL || Manufactured in Germany || Distributed by Roche Diagnostics, Indianapolis, IN
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

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