Events

Recall of Simplastin HTF¿ Reagents, 20ml H¿O, ( and 6 ml H¿O) bioMerieux, Inc., Durham, NC 27704

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BIOMERIEUX, 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
    31482
  • Event Risk Class
    Class 1
  • Event Number
    Z-0843-05
  • Event Initiated Date
    2005-03-07
  • Event Date Posted
    2005-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37971
  • 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
    The isi labeling for simplastin¿ htf on the coag-a-mate¿ max and thrombolyzer instrument platforms is not correct. the simplastin htf isi assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.
  • Action
    Consignees were notified by letter on/about March 7, 2005.

Device

Simplastin HTF¿ Reagents, 20ml H¿O, ( and 6 ml H¿O) bioMerieux, Inc., Durham, NC 27704
  • Model / Serial
    Product numbers 259846, 259847, Lot numbers: 161849, 161800 and 161798. Recall Expanded (03/23/2005) to include these additional lot numbers: 161655, 161710, 161741, 161738, 161742, 1621739, 161743, 161740, 161764, 161763, 161797 and 161799.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand
  • Product Description
    Simplastin HTF¿ Reagents, 20ml H¿O, ( and 6 ml H¿O) bioMerieux, Inc., Durham, NC 27704
  • Manufacturer
    BIOMERIEUX, INC.

Manufacturer

BIOMERIEUX, INC.
  • Manufacturer Address
    BIOMERIEUX, INC., 100 Rodolphe St, Durham NC 27712-9402
  • Source
    USFDA