BEUDAMED
    FDA Recall Terminated

    Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.

    Recall: Z-0273-04 · Initiated November 3, 2003

    Recall

    Recall Number
    Z-0273-04
    Event Number
    27713
    Firm
    Remel, Inc.
    FEI Number
    1924669
    Product Code
    LJG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2003
    Posted
    December 25, 2003
    Terminated
    January 13, 2004
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.

    Reason

    Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area

    Action

    Letters dated 10/29/03 were issued via regular mail on 11/3/03 requesting the customer to discard remaining inventory of the lot.

    Distribution

    Distribution was made to medical facilities, laboratories, and military facilities located in NY, MN, PA, VA, MI, NM, RI, IN, MA, WI, CT, OH, and NC.

    Quantity

    25 boxes