Recall Z-0837-2013 ยท GJS Test, Time, Prothrombin
International Technidyne Corp.
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.
| Date | Feb 19, 2013 (initiated Sep 28, 2012) |
| Status | Terminated |
| Reason | Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. |
| Root cause | Process change control |
| 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 ProTime@itcmed.com. For questions regarding this recall call 800-631-5945, ext. 4707. |
| Quantity | 11,742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE International Technidyne Corp., Jul 2, 2001 |