Recall Z-0881-2015— Alere San Diego, Inc.

Name: FDA recall Z-0881-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-05

Class I · Terminated

Class I FDA medical device recall by Alere San Diego, Inc., initiated 2014-12-05, terminated 2017-09-18. It names 3 FDA 510(k) clearances: K092987, K021923, K020679. Product: INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.. Reason: In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed..

Recalling firm: Alere San Diego, Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-12-05
Terminated: 2017-09-18
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

3 on FDA's record

K092987 — INRATIO/INRATIO2 TEST STRIPSBiosite Incorporated·cleared 2010-06-11
K021923 — INRATIO SELF-TESTHemosense, Inc.·cleared 2002-10-24
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

INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.

Reason for recall

In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.

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