Recall Z-2356-2016— Alere San Diego, Inc.

Name: FDA recall Z-2356-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-11

Class I · Terminated

Class I FDA medical device recall by Alere San Diego, Inc., initiated 2016-07-11, terminated 2017-07-20. It names one FDA 510(k) clearance: K020679. Product: Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.. Reason: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory..

Recalling firm: Alere San Diego, Inc.
Classification: Class I
Status: Terminated
Initiated: 2016-07-11
Terminated: 2017-07-20
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K020679 — INRATIOHemosense, Inc.·cleared 2002-05-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.

Reason for recall

Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

Data sourced from openFDA. This site is unofficial and independent of the FDA.