BEUDAMED
    FDA Enforcement Class II Terminated

    MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.

    Recall: Z-2768-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2768-2015
    Event ID
    71993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MedtestDx, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 23, 2015
    Initiation Date
    May 15, 2015
    Classification Date
    September 15, 2015
    Termination Date
    May 23, 2016
    Address
    5449 Research Dr, Canton, MI, 48188-2261, United States

    Description

    MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.

    Reason

    Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.

    Code Info

    Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07

    Distribution

    US Nationwide Distribution.

    Quantity

    79 kits