BEUDAMED
    FDA Enforcement Class III Terminated

    PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

    Recall: Z-0312-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0312-2017
    Event ID
    75375
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 2, 2016
    Initiation Date
    June 1, 2016
    Classification Date
    October 25, 2016
    Termination Date
    November 8, 2016
    Address
    7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, 21152-9212, United States

    Description

    PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

    Reason

    BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year). The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.

    Code Info

    Part/Catalog Number.: 440911 Lot / Serial Number. 5327782

    Distribution

    BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers. US: AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI. Ex-US: Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and Vietnam 4 US government sites were contacted

    Quantity

    94