BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1835-2021 · Initiated April 16, 2021

    Recall

    Recall Number
    Z-1835-2021
    Event Number
    87850
    Firm
    Hardy Diagnostics
    FEI Number
    2022807
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 16, 2021
    Terminated
    July 28, 2022
    Address
    1430 W McCoy Ln, Santa Maria, CA, 93455-1005

    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.

    Action

    On 05/06/2021, Hardy Diagnostics issued an Urgent Medical Device Removal notice to customers via letter notifying them the GramPro 1 Automated Slide Stainer may have defective tubing, part of the pump mechanism within the unit.

    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