Events

Recall of Device Recall ProTimePROTIMEINT

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

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
    45809
  • Event Risk Class
    Class 2
  • Event Number
    Z-0548-2008
  • Event Initiated Date
    2007-11-19
  • Event Date Posted
    2008-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66197
  • 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
    Microcoagulation System - Product Code GJS
  • Reason
    An increase in the frequency of non-conformance reports (ncmr) for certain displayed error messages at the point of routine quality control checks for the protime microcoagulation system.
  • Action
    ITC sent to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices.

Device

Device Recall ProTimePROTIMEINT
  • Model / Serial
    All instruments with Serial Number V56560 or lower.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany, Switzerland., Singapore, Korea, Indonesia, Lichtenstein, Israel, Saudi Arabia, Latvia, Kuwait, and Slovenia.
  • Product Description
    ProTime Microcoagulation System Instrument:Catalogue Number: || PROTIMEINT, International Technidyne Corporation (ITC), Piscataway, NJ 08854
  • Manufacturer
    International Technidyne Corporation

Manufacturer

International Technidyne Corporation
  • Manufacturer Address
    International Technidyne Corporation, 20 Corporate Pl S, Piscataway NJ 08854-6144
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA