Events

Recall of Device Recall Troponin I Immunoassay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, 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
    61249
  • Event Risk Class
    Class 1
  • Event Number
    Z-1387-2012
  • Event Initiated Date
    2012-03-12
  • Event Date Posted
    2012-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107659
  • 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
    An investigation has confirmed a considerably reduced recovery of li-heparin plasma samples for troponin i lot 163176 and troponin i stat lot 163177. in the worst case, li-heparin sample recovery may be as low as 50% of the serum recovery. correct serum recovery has been confirmed for the affected lots. the issue is caused by the raw material lot (poly-l-lysin) instability. poly-l-lysin is the.
  • Action
    The firm, Roche Diagnostics Corporation, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 12, 2012 to all customers that received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the affected product; discard the affected product from their inventory according to their site's local regulations; if their facility has distributed the affected product to other sites, ensure that this letter is provided to those sites; complete and return the attached fax form via fax to 1-888-912-8457 and file this letter for future references. If you have any questions about the information contained in this letter, please contact Roche Diagnostics Technical Support, 24 hours a day, seven days a week at 1-800-428-2336.

Device

Device Recall Troponin I Immunoassay
  • Model / Serial
    Elecsys Troponin I Immunoassay, 05094810160- lot 163176
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. Argentina, Kenya, Austria, South Korea, Belgium, Kuwait, Bahrain, Morocco, Brazil, Mexico, Switzerland, Nigeria, Chile, New Zealand, Columbia, Philippines, Germany, Pakistan, Algeria, Poland, Egypt, Qatar, Spain, Tunisia, France, Turkey, United Kingdom, Taiwan, India, Ukraine, Iran, Venezuela, Italy, South Africa, Jordan, and Armenia.
  • Product Description
    Elecsys Troponin I Immunoassay || For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA