BEUDAMED
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    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRG·May 15, 2017

    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·September 20, 2017

    RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).

    FDA Recall
    Terminated ·Thera Test Laboratories, Inc.·Product code DHR·March 29, 2012

    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code DHR·November 9, 2001

    SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DHR·June 21, 2010

    RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

    FDA Recall
    Terminated ·Product code DHR·February 13, 2018

    Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DHR·August 9, 2019

    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DHR·January 27, 2012

    Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DHR·January 4, 2018

    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHR·May 10, 2019

    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DHR·May 31, 2011

    Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DHR·November 6, 2019

    VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DHR·November 10, 2011

    Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DHR·October 7, 2019

    SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DHR·June 20, 2011

    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Orthopaedics Ltd. (Aurora)·August 18, 2021

    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

    FDA Recall
    Terminated ·Smith & Nephew Orthopaedics Ltd. (Aurora) Aurora, Spa Park Harrison Way Leamington Spa United Kingdom·Product code NXT·July 14, 2021

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015

    Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·September 16, 2015