Events

Recall of Elecsys Troponin T STAT

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
    26091
  • Event Risk Class
    Class 2
  • Event Number
    Z-0871-03
  • Event Initiated Date
    2003-04-25
  • Event Date Posted
    2003-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27064
  • 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
    Immunoassay Method, Troponin Subunit - Product Code MMI
  • Reason
    Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
  • Action
    An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.

Device

Elecsys Troponin T STAT

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
  • Source
    USFDA