Recall Z-0547-2008
International Technidyne Corporation · initiated November 19, 2007
Product
ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPST, International Technidyne Corporation (ITC), Piscataway, NJ 08854
Codes / lots: All instruments with Serial Number V56560 or lower.
Reason for recall
An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the point of routine Quality control checks for the Protime Microcoagulation System.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0547-2008
- Initiated
- November 19, 2007
- Posted by FDA
- January 25, 2008
- Terminated
- August 12, 2008
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 914
- 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.
- Recalling firm
- International Technidyne Corporation, Piscataway, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0546-2008 | ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International…An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages. | 11/19/2007Terminated |
| Z-0548-2008 | ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International…An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the… | 11/19/2007Terminated |