BEUDAMED
    FDA Enforcement Class III Terminated

    CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan¿ Dx Pre-PCR (-20¿C) MOD T E W, CytoScan¿ Dx Pre-PCR (2¿-8¿C) MOD F L H, CytoScan¿ Dx Post-PCR (-20¿C) MOD S AH W PB, CytoScan¿ Dx Post-PCR (2¿-8¿C) MOD E PW, CytoScan¿ Dx Post-PCR (15¿- 30¿ C) CytoScan Dx WS A CytoScan Dx WS B CytoScan¿ Dx Array kit, 6Pk ChAS Dx Analysis Software and Browser

    Recall: Z-1909-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1909-2016
    Event ID
    73979
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Affymetrix Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    April 14, 2016
    Classification Date
    June 2, 2016
    Termination Date
    August 17, 2016
    Address
    26111 Miles Rd, N/A, Warrensville Heights, OH, 44128-5933, United States

    Description

    CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan¿ Dx Pre-PCR (-20¿C) MOD T E W, CytoScan¿ Dx Pre-PCR (2¿-8¿C) MOD F L H, CytoScan¿ Dx Post-PCR (-20¿C) MOD S AH W PB, CytoScan¿ Dx Post-PCR (2¿-8¿C) MOD E PW, CytoScan¿ Dx Post-PCR (15¿- 30¿ C) CytoScan Dx WS A CytoScan Dx WS B CytoScan¿ Dx Array kit, 6Pk ChAS Dx Analysis Software and Browser

    Reason

    During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.

    Code Info

    4044094 exp 6/10/17; 4044095 exp 6/10/17 ;4044148 exp 10/14/17 ;4044149 exp 10/14/17 ;4044150 exp 12/17/17; 4044151 exp 12/17/17 ; 4044160* exp 3/31/15 and 4244477* exp 12/31/15. *Expiry of initial commercial lots was 12 -18 months.

    Distribution

    Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.

    Quantity

    507 kits