Events

Recall of Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.

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

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
    29060
  • Event Risk Class
    Class 1
  • Event Number
    Z-1001-04
  • Event Initiated Date
    2004-05-05
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33084
  • 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
    Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
  • Reason
    Tecan software has the potential to match the patient with a different patient's test results.
  • Action
    Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to user laboratories.

Device

Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
  • Model / Serial
    All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Tennessee, Texas and Wisconsin.
  • Product Description
    Tecan clinical workstation; Tecan Genesis 150/8 front end COBAS, Roche catalog number 03600530001.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA