Events

Recall of Stratus CS Acute Care Troponin I CalPak

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
    52007
  • Event Risk Class
    Class 2
  • Event Number
    Z-1555-2009
  • Event Initiated Date
    2008-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81883
  • 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
    The firm received and confirmed that some lots of cardiac troponin i (ctnl) calpaks (cctni-cr) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of ctnl testpaks (cctni). this issue may result in failed calibrations due to "slope error" messages or falsely elevated patient sample and quality control (qc) results on calibrations that.
  • Action
    Siemens Healthcare Diagnostics, Inc. issued an Urgent Field Safety Notice dated April 29, 2008 to all affected customers instructing them to discontinue use of 3 CalPak lots and reduce the shelf-life for the remaining lots. For further information, contact Siemens Healthcare Diagnostics, Inc. at 1-302-631-7672.

Device

Stratus CS Acute Care Troponin I CalPak
  • Model / Serial
    Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - including United States, United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia and Bengal.
  • Product Description
    Siemens Stratus CS Acute Care Troponin I CalPak. || In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer.
  • 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