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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 67910
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 2014-03-20
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Alere Triage® BNP Test For the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage® BNP test is a two-site immunoenzymatic (sandwich) assay. A sample is added to a reaction vessel with mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse Omniclonal anti-human BNP antibody. BNP in human plasma binds to the immobilized anti-BNP on the solid phase, while the mouse anti-BNP conjugate reacts specifically with bound BNP. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A chemiluminescent substrate, Lumi- Phos* 530, is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BNP in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve. The Alere TriageR BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: · as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) · as an aid in the assessment of severity of congestive heart failure · for the risk stratification of patients with acute coronary syndromes · for the risk stratification of patients with heart failure Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14 Class II Alere San Diego, Inc. initiated recall of Alere Triage® BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Lots 329599 and 331265, because these lots may not recover within range when tested using certain commercially available controls. 12,592 kits Z-1540-2014
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