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.
FDA Recall Z-2953-2011 · Posted 2011-08-05
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Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeJPA
Date Initiated2011-05-10
Date Terminated2012-11-02
Product Quantity6,218 boxes in US ; 4713 boxes outside US
Reason for Recall
Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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