Events

Recall of CoagAMate

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
    28595
  • Event Risk Class
    Class 3
  • Event Number
    Z-0771-04
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32194
  • 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
    Instrument, Coagulation, Automated - Product Code GKP
  • Reason
    Typographical error in the operator manual. in chapter 11 of the mtx/mtx ii operator manual, the numerical range for the warning flag is shown as 00-99. the correct numerical range is 0-99. the 'list of error and warning' chart shows a numerical range representing the codes 00-9. the correct numerical range for the first ten error/warning codes are 0-9.
  • Action
    Consignees were notified by letter on September 29, 2003.

Device

CoagAMate
  • Model / Serial
    All Codes
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, HK, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, N. Zealand, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, UK.
  • Product Description
    Coag-A-Mate¿ MTX and MTX II Instrument Operator Manual
  • Manufacturer
    Biomerieux, Inc.

Manufacturer

Biomerieux, Inc.
  • Manufacturer Address
    Biomerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Source
    USFDA