Recall Z-1256-2009 ยท GJS Test, Time, Prothrombin
HemoSense Inc
HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
| Date | May 22, 2009 (initiated Dec 23, 2008) |
| Status | Terminated |
| Reason | INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result. |
| Root cause | Nonconforming Material/Component |
| Action | Letters for each product titled "Urgent: Medical Device Recall Notice" dated December 19, 2008 were issued explaining the problem and instructing users to discontinue use, complete the provided reply form and return the device by mail to Inverness Medical. Distributors of the violative device were instructed to contact their customers and provide the same recall information. Further questions should be addressed to HemoSense Technical Service at 1-877-441-7440. |
| Quantity | 921 units |
| Distribution | Worldwide Distribution in the US, Germany, Spain and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072727 | INRATIO 2 PT MONITORING SYSTEM Hemosense, Inc., Oct 26, 2007 |