Recall Z-0837-2013— International Technidyne Corp.

Name: FDA recall Z-0837-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-28

Class II · Terminated

Class II FDA medical device recall by International Technidyne Corp., initiated 2012-09-28, terminated 2014-01-09. It names one FDA 510(k) clearance: K010599. Product: 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.. Reason: Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results..

Recalling firm: International Technidyne Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-09-28
Terminated: 2014-01-09
Firm location: Edison, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K010599 — PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTEInternational Technidyne Corp.·cleared 2001-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.