Events

Recall of Device Recall Stratus CS Acute Care Troponin I TestPak

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dade Behring, 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
    49711
  • Event Risk Class
    Class 2
  • Event Number
    Z-0668-2009
  • Event Initiated Date
    2008-06-23
  • Event Date Posted
    2009-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74061
  • 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
    in vitro diagnostic - Product Code JHX
  • Reason
    Incorrect result: potential for false elevation of ctni results.
  • Action
    Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.

Device

Device Recall Stratus CS Acute Care Troponin I TestPak
  • Model / Serial
    Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
  • Product Description
    Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
  • Manufacturer
    Dade Behring, Inc.

Manufacturer

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