BEUDAMED
    FDA Enforcement Class II Terminated

    Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.

    Recall: Z-1835-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1835-2021
    Event ID
    87850
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 16, 2021
    Initiation Date
    April 16, 2021
    Classification Date
    June 9, 2021
    Termination Date
    July 28, 2022
    Address
    1430 W McCoy Ln, N/A, Santa Maria, CA, 93455-1005, United States

    Description

    Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.

    Reason

    Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

    Code Info

    Lot Numbers: 1654, 1657, 1658, 1660, 1661, 1662, 1663. Serial Numbers: 354, 417, 422, 462, 472, 473, 480, 488, 490, 491, 496, 503, 505, 513, 521, 522, 526, 536, 551, 562, 564, 589, 590, 592, 596, 603, 606, 616, 620, 621, 622, 623, 624, 625, 626, 627, 628, 629, 630, 631, 632, 633, 634, 635, 636, 637, 638, 639, 640, 641, 642, 643, 644, 645, 646, 647, 648, 649, 650, 651, 652, 653, 654, 655, 656, 657, 658, 2005,2012

    Distribution

    US Nationwide distribution in the states of AK, AR, AZ, CA, GA, KS, MA, MI, MN, MS, NY, OH, PA, RI, SC, TN, TX, WI, WV.

    Quantity

    69 units