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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description Product Brand Name: Alere INRatio®2 PT/INR Professional Test Strips Model Number: 99008G2 Product Usage: Usage: Indications for use: The Alere INRatio®2 PT/INR Monitoring System (Professional Use), consisting of the INRatio®2 Monitor and INRatio®2 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 health care professionals. The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. Limitations: The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
Recall Number Z-1546-2014
Classification Class I
Code Info Lot/Unit Codes: Applicable to all Alere INRatio®2 PT/INR Professional Test Strips lots packaged from 8/22/13 through 3/28/14, including the following: 324810, 324811, 324812, 327543, 327544, 327549, 328109, 328705, 328707, 330238, 330852, 331340, 331916, 331922, 332841, 332842, 332843, 332959, 333362, 333654, 333655, 333864, 333865, 334572, 334575, 335552, 335553, 335796, 335797, 336426, 336668, 337350, 338965, 338966, 339257, 339707, 327856V Expiration date, or Expected shelf life: range from 4/30/14 to 1/31/15
Product Distributed Qty Estimated 99,795 Total units
Reason For Recall Alere San Diego is initiating a voluntary recall for the Alere INRatio®2 PT/INR Professional Test Strips. This action is being initiated as a result of several complaints of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio®2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

Event Detail

Event Id 68038
Product Type Devices
Status Ongoing
Recalling Firm Alere San Diego, Inc.
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution
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