Alere San Diego, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1546-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and 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. (in vitro diagnostic use).

Product Classification:

Class I

Date Initiated: April 16, 2014

Date Posted: May 14, 2014

Recall Number: Z-1546-2014

Event ID: 68038

Reason for Recall:

Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

Status: Terminated

Product Quantity: Estimated 99,795 Total units

Code Information:

Lot/Unit Codes: Applicable to all Alere INRatio2 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

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated