Recall Z-2359-2016— Alere San Diego, Inc.

Name: FDA recall Z-2359-2016
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: K110212. Product: Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home Monitoring System is not intended to be used for screening purposes.. Reason: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (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

K110212 — INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIPAlere San Diego, Inc (Formally Biosite Incorporate·cleared 2012-05-01

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 INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home Monitoring System is not intended to be used for screening purposes.

Reason for recall

Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (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.