BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    A2613 SPINAL(FL)W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    A2654-24 SPINAL (FL) W/DRUGS

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips

    FDA Recall
    Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

    LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes

    FDA Recall
    Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

    LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)

    FDA Recall
    Terminated ·LW Scientific, Inc.·Product code JQC·February 6, 2019

    Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·April 10, 2014

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    Nichols Advantage TSH - Third Generation

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code JLW·April 28, 2005

    3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.

    FDA Recall
    Terminated ·3M Company Health Care Business 3M Center·Product code ELW·November 21, 2013

    ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·April 10, 2014

    Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code ELW·November 4, 2010

    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 20, 2015

    ADVIA Centaur XPT Immunoassay System

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 28, 2016

    VITROS Immunodiagnostic Products TSH Reagent Pack

    FDA Recall
    Terminated ·Clinical Diagnostic Systems·Product code JLW·January 11, 2018

    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

    FDA Recall
    Terminated ·Kerr Corporation·Product code ELW·February 21, 2012

    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013