Recall of Device Recall DispoSystem for BCT System

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
    30005
  • Event Risk Class
    Class 2
  • Event Number
    Z-0042-05
  • Event Initiated Date
    2004-08-27
  • Event Date Posted
    2004-10-23
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2005-05-10
  • Event Source
    USFDA
  • Event Source URL
  • 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
    System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
  • Reason
    Aptt determinations when using affected rotors may lead to incorrectly shortened times.
  • Action
    The recalling firm issued a recall letter dated 8/27/04 to their direct accounts informing them of the problem. The recalling firm also sent instructions for a work around until a solution can be established.

Device

  • Model / Serial
    Lot numbers 57295, 57304, 57400, 57463, 57504, 57562, 57579, 57601, 57674, 57685, 57755, 57819, 57820, and 57832
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide. The product was shipped to one government facility in TN.
  • Product Description
    DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
  • Manufacturer

Manufacturer

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