Events

Recall of Device Recall Dimension Vista(R) Cardiac Troponin I Calibrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    60643
  • Event Risk Class
    Class 2
  • Event Number
    Z-0513-2012
  • Event Initiated Date
    2011-11-17
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106113
  • 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
    troponin in vitro diagnostic - Product Code JIT
  • Reason
    Siemens healthcare diagnostics has confirmed positive bias on qc and patients.
  • Action
    Siemens healthcare Diagnostics initiated their recall of lot 1DD085 on November 17, 2011 by sending an Urgent Field Safety Notice letter to all affected customers. Customers were requested to immediately discontinue use and discard any remaining inventory of the CTNI CAL lot 1DD085.

Device

Device Recall Dimension Vista(R) Cardiac Troponin I Calibrator
  • Model / Serial
    Lot number 1DD085
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Slovenia, South Korea, Spain and Switzerland.
  • Product Description
    Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA