Recall Z-0893-2011
International Technidyne Corp. · initiated March 31, 2010
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.
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0893-2011
- Initiated
- March 31, 2010
- Posted by FDA
- March 1, 2011
- Terminated
- September 25, 2012
- Product code
- RFZ – Upc Scanner Reader (Bar Code Reader)
- 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.
- Recalling firm
- International Technidyne Corp., Edison, NJ