Pro Time Microcoagulation System/ Pro Time 3 Cuvette — Class II medical device recall Z-0837-2013
Terminated recall by International Technidyne Corp., reported 2013-02-27, distributed nationwide. Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/Int
| Recall number | Z-0837-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Technidyne Corp., Edison, NJ, United States |
| Recall initiated | 2012-09-28 |
| Classified | 2013-02-19 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2014-01-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BM, CA, CH, CL, DE, DK, ES, IT, LT, LV, MY, PH, TW, ZA |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0837-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.