Alere San Diego, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1727-2014)

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 Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage¿ D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.

Product Classification:

Class II

Date Initiated: May 2, 2014

Date Posted: June 18, 2014

Recall Number: Z-1727-2014

Event ID: 68230

Reason for Recall:

Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.

Status: Terminated

Product Quantity: 373 kits

Code Information:

PN 98100, Lot W53884B.

Distribution Pattern:

Nationwide Distribution only.

Voluntary or Mandated:

Voluntary: Firm initiated