ORTHO-CLINICAL DIAGNOSTICS - VITROS NTproBNP Reagent - Class 2 Recall
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk...
Source: Medical Device Recalls - January 4, 2019 Category: Medical Devices Source Type: alerts
Biomerieux France Chemin De L'Or - VIDAS NT PRO BNP 2 - Class 3 Recall
VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 11, 2016 Category: Medical Equipment Source Type: alerts
Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - July 5, 2016 Category: American Health Source Type: alerts
Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 7, 2016 Category: American Health Source Type: alerts
Super Herbs Capsules: Recall - Undeclared Drug Ingredients
Product poses significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - April 12, 2016 Category: American Health Source Type: alerts
Medtronic Inc. Cardiac Rhythm Disease Management - Medtronic Model 5392 DualChamber Temporary External Pulse Generator - Class 2 Recall
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for tempor...
Source: Medical Device Recalls - April 1, 2015 Category: Medical Equipment Source Type: alerts
Alere San Diego, Inc. - Alere Triage BNP Calibrators For the Beckman Coulter Access Family of Immunoassay Systems - Class 3 Recall
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage 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 patient...
Source: Medical Device Recalls - June 27, 2014 Category: Medical Equipment Source Type: alerts
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 t...
Source: Medical Device Recalls - May 3, 2014 Category: Medical Equipment Source Type: alerts
