Events

Recall of Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.

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
    27989
  • Event Risk Class
    Class 2
  • Event Number
    Z-0331-04
  • Event Initiated Date
    2003-12-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30854
  • 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 (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Reason
    The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
  • Action
    A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.

Device

Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.

Manufacturer

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