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

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    TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    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 Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·October 30, 2013

    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

    SIMPLICITY SOFT QD EASY INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

    ZILVER BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction.

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·June 9, 2005

    MEDICAL COMPRESSOR

    FDA Adverse Event
    Malfunction ·EKOM SPOL. S.R.O.·Product code BTI·April 5, 2011

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 5, 2013

    PENUMBRA SYSTEM SEPARATOR 041

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·March 11, 2011

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·June 12, 2008

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 2, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2020