BEUDAMED
    FDA Enforcement Class III Terminated

    Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.

    Recall: Z-1264-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1264-2015
    Event ID
    70562
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard-Allan Scientific Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    February 19, 2015
    Classification Date
    March 11, 2015
    Termination Date
    January 12, 2016
    Address
    4481 Campus Dr, N/A, Kalamazoo, MI, 49008-2590, United States

    Description

    Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.

    Reason

    The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.

    Code Info

    Lot: 313833 Expiration date: 11/2016

    Distribution

    US, Canada and Europe

    Quantity

    132