Recall Z-0132-06 ยท GJS Test, Time, Prothrombin
HemoSense Inc
HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134
| Date | Nov 15, 2005 (initiated Sep 7, 2005) |
| Status | Terminated |
| Reason | A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition. |
| Root cause | Other |
| Action | On 9/7/05, the firm issued letters via Federal Express and telephone follow-up to all its consignees, informing them of the affected product and providing instructions on the recall. |
| Quantity | 123 units |
| Distribution | Product was released for distribution to 20 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the users who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution. |
| FDA record | Open on fda.gov |