Events

Recall of Device Recall MDA Simplastin L

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
    27008
  • Event Risk Class
    Class 3
  • Event Number
    Z-1239-03
  • Event Initiated Date
    2003-07-31
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29299
  • 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, Time, Prothrombin - Product Code GJS
  • Reason
    Complaints of prolonged clot times.
  • Action
    Consignees were notified via letter on July 31, 2003. The were advised to check remaining inventory and destroy any remaining material of the affected lot numbers. A Customer Response form was attached.

Device

Device Recall MDA Simplastin L
  • Model / Serial
    Product #252555, Lot #500065, 500066 and 500067
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
  • Product Description
    MDA¿ Simplastin¿ L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.
  • Manufacturer
    bioMerieux

Manufacturer

bioMerieux
  • Manufacturer Address
    bioMerieux, 100 Rodolphe Street, Building 1300, Durham NC 27712
  • Source
    USFDA