ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International Technidyne Corporation (ITC), Pis
FDA device recall Z-0548-2008 · posted 2008-01-25 · Terminated
Recall details
- Recalling firm
- International Technidyne Corporation
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 1,514 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, Kuw
- Date initiated
- 2007-11-19
- Date posted
- 2008-01-25
- Date terminated
- 2008-08-12
- Location
- Piscataway, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROTIME MICROCOAGULATION SYSTEM (K951072) | International Technidyne Corp. | 1995-10-27 |