BEUDAMED
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    Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JGJ·November 13, 2020

    Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code JGJ·December 22, 2003

    VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JGJ·June 12, 2013

    Magnesium on RX Imola analyser IVD

    FDA Recall
    Terminated ·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JGJ·April 14, 2016

    Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JGJ·February 17, 2012

    ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).

    FDA Recall
    Terminated ·Horiba Instruments, Inc dba Horiba Medical·Product code JGJ·August 11, 2014

    ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JGJ·January 2, 2019

    AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JGJ·December 8, 2021

    Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JGJ·September 30, 2015

    Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JGJ·November 13, 2020

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    Access Immunoassay Systems Part Number: 81600 Access 2 Immunoassay Systems Part Number: 81600N Access Immunoassay Systems LXi 725 Part Number: 386200 Subsequent Product Codes: JGS The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·April 15, 2011

    ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CGJ·March 5, 2018

    ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGJ·August 7, 2012

    Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.

    FDA Recall
    Terminated ·Selectivemed Components Inc·Product code EGJ·March 15, 2005

    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code CGJ·November 5, 2012

    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code CGJ·November 16, 2016

    iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

    FDA Recall
    Terminated ·Tapemark Company·Product code EGJ·November 10, 2021

    Hidrex USA DVP1000

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017

    Hidrex USA DP450

    FDA Recall
    Terminated ·Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany·Product code EGJ·January 30, 2017