BEUDAMED
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    APTIMA VAGINAL SPECIMEN COLLECTION KIT

    FDA Adverse Event
    Malfunction ·GEN-PROBE, INC.·Product code LSL·June 15, 2010

    MTD TEST

    FDA Adverse Event
    Injury ·GEN-PROBE, INC.·Product code GRT·October 25, 1996

    APTIMA

    FDA Adverse Event
    GEN-PROBE, INC.·Product code MKZ·September 3, 2013

    ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT

    FDA Adverse Event
    Injury ·GEN-PROBE, INC.·Product code MDK·August 13, 2010

    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Enforcement
    Class III ·Terminated·Gen-Probe Inc·June 25, 2014

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·May 2, 2007

    Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·December 30, 2008

    Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

    FDA Recall
    Terminated ·Gen Probe Inc·Product code NDZ·June 11, 2004

    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code OIE·April 17, 2014

    UNICEL DXC 600 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 20, 2011

    COBAS 6000 C (501) MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 16, 2023

    LEEP SYSTEM 1000 ESU GEN.

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·August 13, 2020

    AIA-360

    FDA Adverse Event
    Malfunction ·TOSOH BIOSCIENCE, INC.·Product code KHO·June 25, 2018

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 31, 2012

    AIA-360

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code KHO·March 12, 2018