BEUDAMED
    23 results · 16ms · Sources: EU EUDAMED, US FDA

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    Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code GGT·February 3, 2025

    YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.

    FDA Recall
    Open, Classified ·Young Dental Mfg Co I LLC·Product code JOJ·December 29, 2021

    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code MOI·July 6, 2021

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OOI·June 22, 2022

    Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code MOI·July 6, 2021

    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·October 12, 2022

    PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OOI·December 15, 2023

    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·November 11, 2022

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·April 5, 2022

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Recall
    Open, Classified ·Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium·Product code OOI·December 10, 2024

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

    Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OOI·February 15, 2022

    Alinity m System, Part Number: 08N53-002

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·March 20, 2024

    Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·December 9, 2022

    The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·March 20, 2025

    Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·February 1, 2024

    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OOI·November 19, 2021

    Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code MOI·July 6, 2021

    cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code OOI·November 16, 2021

    Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code MOI·July 18, 2022