Recall Z-1727-2014— Alere San Diego, Inc.

Name: FDA recall Z-1727-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-02

Class II · Terminated

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2014-05-02, terminated 2015-02-27. It names one FDA 510(k) clearance: K042890. Product: 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.. Reason: 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..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-02
Terminated: 2015-02-27
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K042890 — TRIAGE D-DIMER TEST, MODEL 98100Biosite Incorporated·cleared 2004-11-29

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

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.

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.

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