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.
This recall has been terminated (originally issued May 22, 2009).
- Company
- Hemosense Inc
- Recall Initiated
- December 23, 2008
- Posted
- May 22, 2009
- Terminated
- March 25, 2011
- Recall Number
- Z-1256-2009
- Quantity
- 921 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution in the US, Germany, Spain and Australia.
Lot / Code Info
Product Numbers: 0200431 and 0200432.
Root 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.