International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Prot
FDA device recall Z-0470-2007 · posted 2007-01-13 · Terminated
Recall details
- Recalling firm
- International Technidyne Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 1,541 units
- Distribution
- Nationwide to health care professionals and ITC distributors
- Date initiated
- 2006-12-06
- Date posted
- 2007-01-13
- Date terminated
- 2007-04-26
- Location
- Edison, 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 |