Recall Z-0470-2007 ยท GJS Test, Time, Prothrombin
International Technidyne Corp.
International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol.
| Date | Jan 13, 2007 (initiated Dec 6, 2006) |
| Status | Terminated |
| Reason | Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature. |
| Root cause | Other |
| Action | Medical Device Correction letters were sent on 12/6/2006 by first class mail along with a replacement Operator's manual. On 3/19/07 the firm sent and additional letter to customers in order to ensure that self testers, as well as health care professionals and distributors were notified. |
| Quantity | 1,541 units |
| Distribution | Nationwide to health care professionals and ITC distributors |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951072 | PROTIME MICROCOAGULATION SYSTEM International Technidyne Corp., Oct 27, 1995 |