FDA Medical Device Recalls (openFDA)
International Technidyne Corp.: Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is intended to be used only with test cuvettes that are available from ITC.
- Recall number
- Z-0893-2011
- Recalling firm
- International Technidyne Corp.
- Product
- Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is intended to be used only with test cuvettes that are available from ITC.
- Status
- Terminated
- Initiated
- 2010-03-31
- Posted
- 2011-03-01
- Terminated
- 2012-09-25
- Reason
- There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron Signature Elite: some of the devices were inadvertently equipped with class II laser barcode scanner instead of the intended class I barcode scanner.
- Root cause
- Labeling mix-ups
- Action
- Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.
- Quantity
- 1640 units (1303 US, 337 foreign)
- Distribution
- Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
- Lot, serial or model codes
- Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFZ
- Firm FEI
- 1000526865
- Firm city
- Edison
- 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