Events

Recall of The MDA¿ system with MDA¿ Antithrombin III || MDA¿ Heparin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by bioMerieux.

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
    30026
  • Event Risk Class
    Class 2
  • Event Number
    Z-0043-05
  • Event Initiated Date
    2004-06-11
  • Event Date Posted
    2004-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35030
  • 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
    The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.
  • Action
    Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.

Device

The MDA¿ system with MDA¿ Antithrombin III || MDA¿ Heparin
  • Model / Serial
    All product numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK
  • Product Description
    The MDA¿ system with MDA¿ Antithrombin III || MDA¿ Heparin
  • Manufacturer
    bioMerieux

Manufacturer

bioMerieux
  • Manufacturer Address
    bioMerieux, 100 Rodolphe St Bldg 1300, Durham NC 27712-9402
  • Source
    USFDA