BEUDAMED
    87 results · 19ms · Sources: EU EUDAMED, US FDA

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    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DJR--·December 5, 2003

    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.

    FDA Recall
    Terminated ·Alere San Diego Inc. DBA Immunalysis Corporation·Product code DJR·November 28, 2017

    ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DJR--·December 5, 2003

    VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    FDA Recall
    Terminated ·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008

    Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care 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.

    FDA Recall
    Terminated ·Alere San Diego dba Biosite Innovacon Hemosense Inc·Product code DJR·March 12, 2010

    Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care 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.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DJR·May 28, 2009

    VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    FDA Recall
    Terminated ·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008

    Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: 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·May 14, 2012

    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

    ORCHESTRA/ORCHESTRA PLUS Programmer

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia S.r.l.·January 29, 2014

    Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IZI·April 3, 2014

    Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems·May 14, 2014

    7F ZUMA 2 JR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27JR40A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Materialise USA LLC·January 15, 2014

    Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems·June 20, 2018