BEUDAMED
    FDA Enforcement Class II Ongoing

    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    Recall: Z-2200-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2200-2019
    Event ID
    83268
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hycor Biomedical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    March 19, 2018
    Classification Date
    August 6, 2019
    Address
    7272 Chapman Ave, N/A, Garden Grove, CA, 92841-2103, United States

    Description

    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    Reason

    Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.

    Code Info

    All lots of RF assay

    Distribution

    Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India

    Quantity

    288