BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0677-2018 · Initiated November 29, 2017

    Recall

    Recall Number
    Z-0677-2018
    Event Number
    78832
    Firm
    Hologic, Inc.
    FEI Number
    2024800
    Product Code
    LKV
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 29, 2017
    Terminated
    August 22, 2018
    Address
    1240 Elko Dr, Sunnyvale, CA, 94089-2212

    Description

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

    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.

    Action

    Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.

    Distribution

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