International Technidyne Recalls Pro Time 3 Cuvettes for Inaccurate PT/INR Results
International Technidyne Corp. is recalling specific lots of Pro Time 3 Cuvettes because they may produce lower than expected Prothrombin Time/INR results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may produce inaccurate diagnostic results, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
International Technidyne Corp. is recalling specific lots of Pro Time 3 Cuvettes, which are used with the Pro Time Microcoagulation System. The recall involves 11,742 boxes in the United States and 22,968 boxes distributed internationally. The affected products are used for the quantitative determination of prothrombin time from fingerstick or venous whole blood.
The recall is being conducted because some Pro Time 3 Test Cuvettes within the specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. This inaccuracy could affect the reliability of the diagnostic data obtained from the device.
The affected products were distributed nationwide in the United States and internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, and the United Arab Emirates. Users should check their inventory against the specific lot codes listed in the official recall notice and contact International Technidyne Corp. for instructions on returning the affected units.
The recalled product
- 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…
- Manufacturer
- International Technidyne Corp.
Distribution
Distributed nationwide across the United States.
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