BEUDAMED
    FDA Enforcement Class II Terminated

    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

    Recall: Z-0676-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0676-2018
    Event ID
    78832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    November 29, 2017
    Classification Date
    February 21, 2018
    Termination Date
    August 22, 2018
    Address
    1240 Elko Dr, N/A, Sunnyvale, CA, 94089-2212, United States

    Description

    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

    Reason

    Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.

    Code Info

    K6030, L6010, M6007, M6032, A7024, A7056, B7017, B7042, B7057, C7053, D7008, D7043, E7058, E7082

    Distribution

    United States (US), Guam (GU), Japan (JP)

    Quantity

    165 kits