BEUDAMED
    FDA Enforcement Class II Terminated

    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.

    Recall: Z-2196-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2196-2013
    Event ID
    65980
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Assuramed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    July 16, 2013
    Classification Date
    September 13, 2013
    Termination Date
    December 27, 2017
    Address
    1810 Summit Commerce Par, K, Twinsburg, OH, 44087, United States

    Description

    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.

    Reason

    The products may have been stored at temperatures outside their required storage conditions.

    Code Info

    Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004

    Distribution

    Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.

    Quantity

    10 units