BEUDAMED
    FDA Recall 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 · Initiated February 19, 2015

    Recall

    Recall Number
    Z-1264-2015
    Event Number
    70562
    Firm
    Richard-Allan Scientific Company
    FEI Number
    1831638
    Product Code
    HZJ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 19, 2015
    Posted
    March 11, 2015
    Terminated
    January 12, 2016
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590

    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.

    Action

    Urgent Medical Device Recall letters sent to Richard Allan distributors and customers. The recall notification includes the reason for the voluntary recall, risk to health, product information and actions to be taken by the distributor/customer.

    Distribution

    US, Canada and Europe

    Quantity

    132