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    The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient s age, previous biopsy, and digital rectal exam (DRE).

    FDA Recall
    Open, Classified ·BioReference Health, LLC·Product code QRF·October 31, 2023

    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.

    FDA Recall
    Open, Classified ·BioReference Health, LLC·Product code QRF·November 18, 2022

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Recall
    Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 2023

    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MTF·December 21, 2016

    IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MTF·November 18, 2016

    IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MTF·November 18, 2016

    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MTF·December 21, 2016

    PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code MFT·June 26, 2013

    Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRE·November 3, 2011

    Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code DRE·March 18, 2004

    ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DRE·February 17, 2016

    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DRE·December 31, 2015

    MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DRE·February 20, 2020

    Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)

    FDA Recall
    Terminated ·Cardiac Assist, Inc·Product code DRE·March 19, 2021

    VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston Scientific.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRE·March 5, 2004

    Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize, Manufactured in USA for VNUS, 5799 Fontanus Way, San Jose CA 95138 USA; General: 408-360-7200. For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DRE·January 6, 2009

    MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781

    FDA Recall
    Open, Classified ·Angiodynamics, Inc.·Product code DRE·January 30, 2024

    Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DRE·September 29, 2009