Events

Recall of Device Recall COBAS TaqMan

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
    25949
  • Event Risk Class
    Class 2
  • Event Number
    Z-0917-03
  • Event Initiated Date
    2003-03-06
  • Event Date Posted
    2003-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26760
  • 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
    Analyzer, Chemistry, Micro, For Clinical Use - Product Code JJF
  • Reason
    A false positive result may be reported.
  • Action
    Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.

Device

Device Recall COBAS TaqMan
  • Model / Serial
    All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia.
  • Product Description
    COBAS TaqMan analyzer, Series 96; catalog number 8080216.
  • Manufacturer
    Roche Molecular Systems Inc

Manufacturer

Roche Molecular Systems Inc
  • Manufacturer Address
    Roche Molecular Systems Inc, 11 Franklin Ave, Belleville NJ 07109
  • Source
    USFDA