Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.
FDA Recall Z-0837-2013 · Posted 2013-02-19
Recalling FirmInternational Technidyne Corp.
Recall StatusTerminated
Product CodeGJS
Date Initiated2012-09-28
Date Terminated2014-01-09
Product Quantity11,742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)
Reason for Recall
Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.
Firm Action
ITC sent an 'Urgent Medical Device Recall' letter/Health Professional Account Tracking Form dated October 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were asked to complete the form whether or not they have remaining inventory of these lots and return the form promptly. All unused returned product will be replaced. Any questions can be directed to ITC Technical Support at 800-631-5945 Extension 4707 or e-mail [email protected].
For questions regarding this recall call 800-631-5945, ext. 4707.
Root Cause
Process change control
Distribution Pattern
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.
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.