Recall Z-0893-2011 ยท RFZ Upc Scanner Reader (Bar Code Reader)
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.
| Date | Mar 1, 2011 (initiated Mar 31, 2010) |
| Status | Terminated |
| 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) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.