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International Technidyne Corp.

Also registered as International Technidyne Corporation

United StatesFDA applicant, unverified

Devices
48
FDA recalls
22

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What International Technidyne Corp. makes

International Technidyne Corp. manufactures coagulation testing devices, including point-of-care analyzers for prothrombin time (PT), activated partial thromboplastin time (APTT), and fibrinogen assays, as well as bleeding time measurement tools. Their portfolio includes systems like the HEMOCHRON series for microcoagulation analysis, the PROTIME Microcoagulation System, and the TENDERFOOT for assessing capillary bleeding time. These devices are designed for clinical and laboratory use to monitor blood clotting parameters.

The company’s coagulation testing devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are intended for use in the United States, where they are subject to FDA oversight for performance and safety in diagnostic testing. No other regulatory registries or jurisdictions are specified for these devices.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue48

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FDA recalls22

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 22 recalls initiated by International Technidyne Corp., the earliest on 2005-04-27 and the most recent on 2012-09-28. By recorded status: 22 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, packaging, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 22 recalls.

  • 2012

    • 28 Sep 2012 Z-0837-2013 Class II Terminated Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy,…
      Full distribution text Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.
      Submission number: K010599

  • 2011

    • 10 May 2011 Z-2953-2011 Unclassified (pre-2012) Terminated Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments. Distribution: Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada,…
      Full distribution text 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.
      Submission numbers: K940432, K974799
    • 10 May 2011 Z-2954-2011 Unclassified (pre-2012) Terminated Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments. Distribution: Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada,…
      Full distribution text 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.
      Submission numbers: K940432, K974799
    • 23 Mar 2011 Z-2218-2011 Unclassified (pre-2012) Terminated An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments. Distribution: Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand Submission number: K951485

  • 2010

    • 30 Nov 2010 Z-1093-2011 Unclassified (pre-2012) Terminated Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot. Distribution: Worldwide Distribution Submission number: K983475
    • 8 Jul 2010 Z-2107-2010 Unclassified (pre-2012) Terminated Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published. Distribution: Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain,…
      Full distribution text Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
      Submission number: K944691
    • 8 Jul 2010 Z-2108-2010 Unclassified (pre-2012) Terminated Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published. Distribution: Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain,…
      Full distribution text Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
      Submission number: K944691
    • 25 Jun 2010 Z-2200-2010 Unclassified (pre-2012) Terminated The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes Distribution: Nationwide and one customer in Belgium. Submission number: K944691
    • 24 Jun 2010 Z-2110-2010 Unclassified (pre-2012) Terminated An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures. Distribution: Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy. Submission number: K904003
    • 15 Apr 2010 Z-1786-2010 Unclassified (pre-2012) Terminated Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect. Distribution: Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia,…
      Full distribution text Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi Arabia.
      Submission number: K944691
Show all 22 recalls

  • 2010

    • 9 Apr 2010 Z-2438-2010 Unclassified (pre-2012) Terminated A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and the Device Performance Summary Reports. The IDMS software is not used for the clinical management of individual patients. Distribution: Worldwide distribution: USA including the states of AL, AZ, CA, FL, GA, IL, KS, LA, MD, MI, NC, ND, NJ, NM, NY, OH, PA,…
      Full distribution text Worldwide distribution: USA including the states of AL, AZ, CA, FL, GA, IL, KS, LA, MD, MI, NC, ND, NJ, NM, NY, OH, PA, TN , TX, UT, VA, WA, and WI, and the countries of Italy, Turkey, Canada, France, Belgium, Germany, UAE, and New Zealand.
    • 31 Mar 2010 Z-0893-2011 Unclassified (pre-2012) Terminated There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron Signature Elite: some of the devices were inadvertently equipped with class II laser barcode scanner instead of the intended class I barcode scanner. Distribution: Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom,…
      Full distribution text Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.

  • 2009

    • 5 May 2009 Z-1732-2009 Unclassified (pre-2012) Terminated One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria. Distribution: Nationwide. Submission number: K960749

  • 2008

    • 13 Feb 2008 Z-1237-2008 Unclassified (pre-2012) Terminated Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers. Distribution: Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece,…
      Full distribution text Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece, Romania, Singapore, ROC, Pakistan, Netherlands, Korea, France, Belgium, Switzerland, Canada, Thailand, Slovenia, Turkey and Australia.
      Submission number: K922075
    • 13 Feb 2008 Z-1238-2008 Unclassified (pre-2012) Terminated Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers. Distribution: Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece,…
      Full distribution text Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece, Romania, Singapore, ROC, Pakistan, Netherlands, Korea, France, Belgium, Switzerland, Canada, Thailand, Slovenia, Turkey and Australia.
      Submission number: K922075
    • 13 Feb 2008 Z-1239-2008 Unclassified (pre-2012) Terminated Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers. Distribution: Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece,…
      Full distribution text Worldwide Distribution: USA, United Arab Emirates, Malaysia, Saudi Arabia, India, Germany, United Kingdom, Greece, Romania, Singapore, ROC, Pakistan, Netherlands, Korea, France, Belgium, Switzerland, Canada, Thailand, Slovenia, Turkey and Australia.
      Submission number: K951485

  • 2007

    • 19 Nov 2007 Z-0546-2008 Unclassified (pre-2012) Terminated An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages. Distribution: Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany,…
      Full distribution text 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.
      Submission number: K010599
    • 19 Nov 2007 Z-0547-2008 Unclassified (pre-2012) Terminated 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. Distribution: Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany,…
      Full distribution text 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.
      Submission number: K961835
    • 19 Nov 2007 Z-0548-2008 Unclassified (pre-2012) Terminated 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. Distribution: Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany,…
      Full distribution text 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.
      Submission number: K951072

  • 2006

    • 6 Dec 2006 Z-0470-2007 Unclassified (pre-2012) Terminated Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature. Distribution: Nationwide to health care professionals and ITC distributors Submission number: K951072
    • 23 Jan 2006 Z-0673-06 Unclassified (pre-2012) Terminated Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product. Distribution: Product was distributed nationwide to medical supply distributors. The product was also shipped internationally to 3…
      Full distribution text Product was distributed nationwide to medical supply distributors. The product was also shipped internationally to 3 countries: Canada, Czech Republic, and New Zealand. There are no Govt. accounts.
      Submission number: K923302

  • 2005

    • 27 Apr 2005 Z-1381-05 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed domestically to customers nationwide. Products were also distributed internationally to…
      Full distribution text 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.
      Submission number: K960749

Frequently asked questions

How many devices does International Technidyne Corp. have in the registry?

The registry currently lists 48 devices for International Technidyne Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list International Technidyne Corp.'s devices?

Among its 48 most recently registered devices, International Technidyne Corp. has devices listed in FDA 510(k) (48 devices).

What risk classes do International Technidyne Corp.'s devices fall under?

Among its 48 most recently registered devices, the classes recorded for International Technidyne Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for International Technidyne Corp.?

FDA recall records list 22 recalls initiated by International Technidyne Corp., the most recent initiated on 28 Sep 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from International Technidyne Corp. in the registry?

The most recently registered devices listed for International Technidyne Corp. include HEMOCHRON(R) KACT, HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE, HEMOCHRON CITRATE APTT and PROTIME MICROCOAGULATION SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.