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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

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.
Recall Number Z-1727-2014
Classification Class II
Code Info PN 98100, Lot W53884B.
Product Distributed Qty 373 kits
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.

Event Detail

Event Id 68230
Product Type Devices
Status Ongoing
Recalling Firm Alere San Diego, Inc.
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution only.