Alere San Diego, Inc. - Cardiac Marker Test - Class 2 Recall

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 ...
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts