Events

Recall of Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.

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
    29648
  • Event Risk Class
    Class 2
  • Event Number
    Z-1431-04
  • Event Initiated Date
    2004-08-06
  • Event Date Posted
    2004-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34720
  • 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
    A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
  • Action
    Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.

Device

Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 0442938...

Manufacturer

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