BEUDAMED
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    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QKP·April 16, 2021

    DAVINCI XI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 7, 2026

    Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LKJ·February 26, 2010

    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

    FDA Recall
    Terminated ·Remel Inc·Product code JTS·October 29, 2014

    RESONANCE STENT SET

    FDA Adverse Event
    Injury ·COOK MEDICAL IRELAND·Product code FAD·September 13, 2022

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 7, 2021

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LOM·July 27, 2012