BEUDAMED
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    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020

    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 23, 2020

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Enforcement
    Class III ·Terminated·DNA Genotek Inc.·September 30, 2020

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Recall
    Terminated ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020

    QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code NQN·November 6, 2008

    Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·August 20, 2007

    GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code MQB·March 26, 2007

    GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System)

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code MQB·March 26, 2007

    GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code MQB·March 26, 2007

    i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code GJS·May 5, 2010

    BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C. For In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

    BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes; Becton Dickinson and Company, Franklin Lakes, NJ

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

    BC Thrombin Reagent . Thrombin Time Test

    FDA Recall
    Terminated ·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code GJA·July 21, 2004

    BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code GJA·October 17, 2017

    MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

    FDA Recall
    Terminated ·bioMerieux·Product code GJA·August 20, 2004

    Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

    FDA Recall
    Terminated ·bioMerieux·Product code GJA·August 20, 2004

    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

    FDA Recall
    Terminated ·OriGen Biomedical, Inc.·Product code KJA·January 28, 2021

    V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Cardinal Health 1430 Waukegan Rd Attn V. Mueller Qa McGaw Park IL 60085·Product code FFL·October 27, 2004

    Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Cardinal Health 1430 Waukegan Rd ATTN: V. MUELLER QA McGaw Park IL 60085·Product code GCB--·November 15, 2002

    Presource PBDS, Shoulder Arthroscopy, Kit, Circulator

    FDA Recall
    Terminated ·Cardinal Health, Medical Products & Services 1430 Waukegan Road Attn V. Mueller Qa Park City IL 60085·Product code OFP·March 26, 2013