BEUDAMED
    FDA Enforcement Class II Terminated

    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.

    Recall: Z-0869-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0869-2014
    Event ID
    67245
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 5, 2014
    Initiation Date
    December 9, 2013
    Classification Date
    January 30, 2014
    Termination Date
    August 20, 2014
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.

    Reason

    Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

    Code Info

    Catalog number 441385 and 441386

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.

    Quantity

    198 units