BEUDAMED
    FDA Recall 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 · Initiated April 4, 2013

    Recall

    Recall Number
    Z-0530-2014
    Event Number
    65477
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JXB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 4, 2013
    Posted
    December 17, 2013
    Terminated
    March 12, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    Thermo Fisher Scientific sent a Medical Device Recall letter dated April 3, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm instructed customer to review their inventory for affected lot and discard the product. A Medical Device Recall Return Response was enclosed for the customer to indicate they understood the instructions and to report the amount of product they discarded. For questions call Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

    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