Recall Z-1256-2009
HemoSense Inc · initiated December 23, 2008
Product
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.
Codes / lots: Product Numbers: 0200431 and 0200432.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1256-2009
- Initiated
- December 23, 2008
- Posted by FDA
- May 22, 2009
- Terminated
- March 25, 2011
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 921 units
- Distribution
- Worldwide Distribution in the US, Germany, Spain and Australia.
- Recalling firm
- HemoSense Inc, San Jose, CA