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Terminated

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.

FDA Recall Z-1256-2009 · Posted 2009-05-22

Recalling FirmHemoSense Inc
Recall StatusTerminated
Product CodeGJS
Date Initiated2008-12-23
Date Terminated2011-03-25
Product Quantity921 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution in the US, Germany, Spain and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072727INRATIO 2 PT MONITORING SYSTEMHemosense, Inc. · 2007-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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