BEUDAMED
    FDA Enforcement Class II Terminated

    remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.

    Recall: Z-0530-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0530-2014
    Event ID
    65477
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    April 4, 2013
    Classification Date
    December 17, 2013
    Termination Date
    March 12, 2014
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.

    Reason

    The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.

    Code Info

    Lot 302532, Exp 6 Feb 2014

    Distribution

    Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, WI and the countries of Canada, UK, and Japan.

    Quantity

    150 kits