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Terminated

HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134

FDA Recall Z-0132-06 · Posted 2005-11-15

Recalling FirmHemoSense Inc
Recall StatusTerminated
Product CodeGJS
Date Initiated2005-09-07
Date Terminated2006-03-30
Product Quantity123 units

Reason for Recall

A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.

Firm Action

On 9/7/05, the firm issued letters via Federal Express and telephone follow-up to all its consignees, informing them of the affected product and providing instructions on the recall.

Root Cause

Other

Distribution Pattern

Product was released for distribution to 20 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the users who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021923INRATIO SELF-TESTHemosense, Inc. · 2002-10-24K020679INRATIOHemosense, Inc. · 2002-05-06

Official Source

View FDA Recall →

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

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