Events

Recall of Device Recall Hemochron JR. Microcoagulation Systems Prothrombin Time (PT).

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
    58043
  • Event Risk Class
    Class 2
  • Event Number
    Z-2953-2011
  • Event Initiated Date
    2011-05-10
  • Event Date Posted
    2011-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98093
  • 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 Systems; Prothrombin Time (PT) - Product Code JPA
  • Reason
    Certain lots of hemochron jr. pt cuvettes (j201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments.
  • Action
    International Technidyne Corp. (ITC) sent "Urgent Medical Device Recall" letters dated May 10, May 25 and June 09, 2011 to all affected customers. The letter included a description of the problem, asked customers fill out the attached form, and return affected product for replacement. For questions, please contact ITC Technical Support at (800) 631-5945.

Device

Device Recall Hemochron JR. Microcoagulation Systems Prothrombin Time (PT).
  • Model / Serial
    Catalogue/Code J201  Lot Number:  FOJPT059, GOJPT067,  GOJPT068,  GOJPT069,  GOJPT070,  GOJPT072,  GOJPT073,  GOJPT074,  GOJPT075,  HOJPT076,  HOJPT077,  HOJPT078,  HOJPT079,  HOJPT080,  HOJPT081,  HOJPT082,  HOJPT083,  JOJPT084,  JOJPT085,  JOJPT086,  JOJPT087,  JOJPT088,  JOJPT090,  KOJPT091,  KOJPT092,  KOJPT093,  MOJPT094,  MOJPT095,  MOJPT096,  MOJPT097,  MOJPT098,  MOJPT099,  A1JPT001,  A1JPT002  A1JPT003  A1JPT005  A1JPT007  A1JPT008,  A1JPT009,  A1JPT010,  A1JPT011,  A1JPT012,  A1JPT013,  A1JPT014,  A1JPT015,  A1JPT016,  A1JPT017,  A1JPT018,  A1JPT019,  A1JPT021,  A1JPT023,  A1JPT024,  A1JPT025,  B1JPT032,  B1JPT033,  C1JPT035,  C1JPT038,  C1JPT041,  and C1JPT045.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.
  • Product Description
    Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). || International Ethidine Corp (ITC)-Nexus Dx. || A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Manufacturer Address
    International Technidyne Corp., 68 Olsen Ave, Edison NJ 08820-2419
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA