Alere San Diego, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0880-2015)

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:

Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).

Product Classification:

Class I

Date Initiated: December 5, 2014

Date Posted: January 14, 2015

Recall Number: Z-0880-2015

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: 77,342 units (12 test strips/box) and 308,947 units (48 test strips/box)

Code Information:

All lots of part numbers: 0100071 and 0100139.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated