FDA Medical Device Recalls (openFDA)
International Technidyne Corporation: ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International Technidyne Corporation (ITC), Piscataway, NJ 08854
- Recall number
- Z-0548-2008
- Recalling firm
- International Technidyne Corporation
- Product
- ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International Technidyne Corporation (ITC), Piscataway, NJ 08854
- Status
- Terminated
- Initiated
- 2007-11-19
- Posted
- 2008-01-25
- Terminated
- 2008-08-12
- Reason
- 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.
- 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
- 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, Kuwait, and Slovenia.
- Lot, serial or model codes
- All instruments with Serial Number V56560 or lower.
- 510(k) numbers
- ["K951072"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 3005776351
- Firm city
- Piscataway
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28