BEUDAMED
    FDA Enforcement Class II Terminated

    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.

    Recall: Z-1895-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-1895-2017
    Event ID
    77011
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard-Allan Scientific Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    March 15, 2017
    Classification Date
    April 28, 2017
    Termination Date
    July 27, 2017
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590, United States

    Description

    Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.

    Reason

    Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.

    Code Info

    Part Number: 9990700 Lot Number S-645, S-646 and S-647 Part Number 9990707 Lot: 234, 235, and 236 Expiration date: 8/18/2018-12/10/2018

    Distribution

    Worldwide Distribution -- US: CA, CO, CT, DE, GA, HI, IA, IL, KS, MA, MS, NC, NH, NM, NY, OH, PA, PR, RI, UT, VA, VT, WA, and WV; and, the countries of AE, BH, CA, CZ, FR, GB, HK, SA, and TR.

    Quantity

    390