BEUDAMED
    FDA Enforcement Class III Terminated

    The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.

    Recall: Z-1840-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1840-2015
    Event ID
    71406
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    May 13, 2015
    Classification Date
    June 25, 2015
    Termination Date
    November 5, 2015
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039, United States

    Description

    The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.

    Reason

    The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.

    Code Info

    lot no. 11130382, expiration date 2016-04-30

    Distribution

    US Distribution to the states of : AZ, CA, ID, MO, and NH.

    Quantity

    20 vials