Events

Recall of Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNID)

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
    35112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0882-06
  • Event Initiated Date
    2006-04-03
  • Event Date Posted
    2006-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45353
  • 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
    Foil sealing of the dilpak may occlude the pipet tip resulting in insufficient aspiration of fluids. erroneous test results may be generated without an associated error code. test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
  • Action
    Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.

Device

Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNID)
  • Model / Serial
    Lot # 835332002 and 836044002
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
  • Product Description
    Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic.
  • Manufacturer
    Dade Behring , Inc.

Manufacturer

Dade Behring , Inc.
  • Manufacturer Address
    Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Source
    USFDA