BEUDAMED
    28 results · 19ms · Sources: EU EUDAMED, US FDA

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    Revogene, Catalog no. 610210. IVD test instrument

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

    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

    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

    Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OOI·June 14, 2023

    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

    FDA Recall
    Open, Classified ·Future Diagnostics Solutions B.V. Nieuweweg 279 Wijchen Netherlands·Product code CEW·December 6, 2022

    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

    FDA Recall
    Open, Classified ·Daavlin Distributing Company·Product code FTC·April 26, 2022

    1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]

    FDA Recall
    Open, Classified ·Daavlin Distributing Company·Product code FTC·April 26, 2022

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code LXH·July 29, 2021

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Recall
    Open, Classified ·Mizuho OSI·Product code GDC·February 8, 2021