BEUDAMED
    76 results · 48ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    *

    FDA Adverse Event
    Other ·TRIAGE MEDICAL INC·Product code DYB·February 5, 2007

    Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DIF·September 23, 2013

    Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the risk stratification of patients with heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes.

    FDA Recall
    Terminated ·Alere San Diego·Product code MMI·March 5, 2012

    Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.

    FDA Recall
    Terminated ·Alere San Diego·Product code MMI·March 5, 2012

    Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code JJY·October 12, 2016

    KANGAROO

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·April 20, 2018

    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 patients with acute coronary syndromes for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·May 30, 2014

    Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DJR·February 5, 2014

    ENTERAL DEVICE DECLOGGING SYSTEM

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·July 23, 2025

    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 intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code NBC·March 20, 2014

    KANGAROO JOEY,PUMP W/POLE CLMP

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·September 9, 2016

    KANGAROO

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·June 5, 2018

    TPW 2X24IN 2-0 D/A SH,SKS-3 BWY

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code LDF·July 30, 2021

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 27, 2021

    KANGAROO

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code KNT·December 14, 2018

    KANGAROO

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·July 31, 2018

    HEPARIN FLUSH

    FDA Adverse Event
    Death ·MEDEFIL·Product code NZW·April 16, 2008

    KANGAROO

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG PLAINFIELD·Product code LZH·March 14, 2017

    KANGAROO

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·February 21, 2017

    KANGAROO

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LZH·July 16, 2018