Events

Recall of Device Recall International Technidyne Corporation

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ITC-Nexus Dx.

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
    67237
  • Event Risk Class
    Class 2
  • Event Number
    Z-0937-2014
  • Event Initiated Date
    2013-12-19
  • Event Date Posted
    2014-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125060
  • 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 partial thromboplastin - Product Code GFO
  • Reason
    Itc has determined that some citrate aptt cuvettes may recover higher than expected results in normal individuals.
  • Action
    The firm, ITC The Point of Care, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2013 a long with an attached Health Professional Account Tracking Form via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to forward this communication to all those within your organization who need to be aware of this matter including any facility that you forwarded any of the affected product to; check all inventory to determine if you have any of the affected lots listed; if you have any affected lots, stop using them, remove from inventory and return to ITC; complete the attached Health Professional Account Tracking Form and return it within 10 days via fax to: 866-429-3132, email: RA@itcmed.com or mail to: ITC Technical Support, 20 Corporate Place South - Piscataway, NJ 08854 . It is important that you complete the form whether or not you have remaining inventory of these lots. In addition, contact ITC Technical Support immediately if you become aware of an unreported adverse event related to the use of affected J103C cuvettes. ITC will review your response form and will contact you to arrange for any inventory to be returned to ITC and ITC will replace all unused, returned product. If you have questions, please contact ITC Technical Support: Telephone 800-579-2255 or 732-548-5700, Extension 4011 or E-mail Techsupport@itcmed.com.

Device

Device Recall International Technidyne Corporation
  • Model / Serial
    E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
  • Product Description
    Hemochron Jr. Citrate APTT Cuvette || 510(k) K014008 || A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
  • Manufacturer
    ITC-Nexus Dx

Manufacturer

ITC-Nexus Dx