BEUDAMED
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    First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·August 18, 2020

    Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine.

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·November 6, 2008

    Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Alere San Diego·Product code DKZ·June 10, 2011

    Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DKZ·June 3, 2013

    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·September 23, 2014

    MEDTOXscan Reader

    FDA Recall
    Terminated ·Medtox Diagnostics Inc·Product code DKZ·February 8, 2008

    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

    SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay 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 Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·April 26, 2011

    Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code DKZ·February 12, 2007

    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

    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    FDA Recall
    Terminated ·Sarken, Inc.·Product code DKZ·July 29, 2013

    ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·September 23, 2014

    ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay 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 Spectroscopy (GC/MS) is the preferred confirmation method.

    FDA Recall
    Terminated ·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·June 7, 2011

    Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.

    FDA Recall
    Terminated ·Alere San Diego·Product code DKZ·July 1, 2011

    ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·September 23, 2014

    AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code DKZ·January 21, 2008

    First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B

    FDA Recall
    Terminated ·Ameditech Inc·Product code DKZ·August 18, 2020

    SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).

    FDA Recall
    Terminated ·Sarken, Inc.·Product code DKZ·July 29, 2013

    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