Recall Z-0546-2008 ยท GJS Test, Time, Prothrombin
International Technidyne Corporation
ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854
| Date | Jan 25, 2008 (initiated Nov 19, 2007) |
| Status | Terminated |
| Reason | An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages. |
| Root cause | Device Design |
| Action | ITC sent to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices. |
| Quantity | 3,482 units |
| Distribution | Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany, Switzerland., Singapore, Korea, Indonesia, Lichtenstein, Israel, Saudi Arabia, Latvia, Kuwait, and Slovenia. |
| 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 |