HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System i
FDA device recall Z-1256-2009 · posted 2009-05-22 · Terminated
Recall details
- Recalling firm
- HemoSense Inc
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 921 units
- Distribution
- Worldwide Distribution in the US, Germany, Spain and Australia.
- Date initiated
- 2008-12-23
- Date posted
- 2009-05-22
- Date terminated
- 2011-03-25
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INRATIO 2 PT MONITORING SYSTEM (K072727) | Hemosense, Inc. | 2007-10-26 |