Events

Recall of Device Recall directCheck

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

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
    56117
  • Event Risk Class
    Class 2
  • Event Number
    Z-2200-2010
  • Event Initiated Date
    2010-06-25
  • Event Date Posted
    2010-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92697
  • 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
    plasma control in vitro diagnostic - Product Code GGN
  • Reason
    The package insert for the directcheck microcoagulation quality control contains an incorrect acceptable performance range regarding act-lr cuvettes.
  • Action
    ITC sent Urgent Medical Device Correction letters on June 25, 2010 by Federal Express to hospital Risk Managers and Lab Directors, Clinical Laboratory Manager or Point-of-Care Coordinators.

Device

Device Recall directCheck
  • Model / Serial
    Catalog number: DCJLR-N; Lot number: M9DNL055, exp. 9/2010
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and one customer in Belgium.
  • Product Description
    International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic || 15 vials || For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Manufacturer Address
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA