Events

Recall of Device Recall BC Thrombin OENA11

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
    29987
  • Event Risk Class
    Class 3
  • Event Number
    Z-0007-05
  • Event Initiated Date
    2004-07-21
  • Event Date Posted
    2004-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34917
  • 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
    Test, Thrombin Time - Product Code GJA
  • Reason
    The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin.
  • Action
    The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.

Device

Device Recall BC Thrombin OENA11
  • Model / Serial
    Lot 540624, Lot 540625, and Lot 540626
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
  • Product Description
    BC Thrombin Reagent . Thrombin Time Test
  • Manufacturer
    Dade Behring , Inc.

Manufacturer

Dade Behring , Inc.
  • Manufacturer Address
    Dade Behring , Inc., Rte 896, Glasgow Business Community, Newark DE 19702
  • Source
    USFDA