Alere San Diego, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0881-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: December 5, 2014

Date Posted: January 14, 2015

Recall Number: Z-0881-2015

Event ID: 69964

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.

Status: Terminated

Product Quantity: 231,967 Test Systems including Monitors

Code Information:

All lots of part numbers: 0100004, 0100007, and 0100137.

Distribution Pattern:

Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.

Voluntary or Mandated:

Voluntary: Firm initiated