Events

Recall of Hemochron

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
    31937
  • Event Risk Class
    Class 3
  • Event Number
    Z-1381-05
  • Event Initiated Date
    2005-04-27
  • Event Date Posted
    2005-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38779
  • 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
    Activated Whole Blood Clotting Time - Product Code JBP
  • Reason
    Validation had been initiated for a molded component of the finished device but not completed. also, the device did not meet mean clotting time using normal donor blood as media.
  • Action
    Recall letter was sent out on 4/27/2005 via First Class Mail.

Device

Hemochron
  • Model / Serial
    Catalog No. JACT-LR Lot No''s:  M4JLR164, Exp. 3/2006; M4JLR165, Exp. 3/2006; A5JLR001, Exp. 4/2006; A5JLR002, Exp. 4/2006; A5JLR003, Exp. 4/2006; C5JLR032, Exp. 6/2006.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were distributed domestically to customers nationwide. Products were also distributed internationally to customers in the following countries: Italy, Sweden, Norway, Germany, and Japan. Products were distributed to the VA Medical Center, Los Angeles, CA 90073.
  • Product Description
    Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Manufacturer Address
    International Technidyne Corp., 6 Olsen Ave, Edison NJ 08820-2419
  • Source
    USFDA