BEUDAMED
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    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089

    FDA Recall
    Terminated ·Cepheid·Product code NJR·September 5, 2007

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code NJR·December 13, 2024

    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·December 1, 2015

    QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·December 1, 2015

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code NJR·March 18, 2022

    Vision Hollow Fiber Oxygenator with GBS Coating

    FDA Recall
    Terminated ·Gish Biomedical Inc·Product code DTZ·March 4, 2004

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code NJR·December 11, 2012

    BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code NQX·May 24, 2011

    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSJ·March 21, 2016

    The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood.

    FDA Recall
    Terminated ·Gish Biomedical Inc·Product code DTZ·November 28, 2005

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    FDA Recall
    Terminated ·Cardinal Health Inc.·Product code PQZ·April 20, 2020

    KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·December 16, 2020

    NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    FDA Recall
    Terminated ·Northeast Laboratory Services, Inc.·Product code JSI·December 21, 2015

    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    FDA Recall
    Terminated ·Northeast Laboratory Services, Inc.·Product code JSI·December 21, 2015

    The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula.

    FDA Recall
    Terminated ·Gish Biomedical Inc·Product code DTZ·November 28, 2005

    Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code NSU·February 26, 2021

    HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008