BEUDAMED
    30 results · 33ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·April 5, 2023

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Recall
    Terminated ·Illumina Inc·Product code PFS·November 6, 2014

    Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205

    FDA Recall
    Open, Classified ·Illumina, Inc.·Product code PFT·October 28, 2025

    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.

    FDA Recall
    Terminated ·Illumina Inc·Product code PFF·July 28, 2014

    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·February 22, 2022

    illumina Model NextSeq 550 Dx REF 20005715

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.

    FDA Recall
    Terminated ·Illumina Inc·Product code PFS·November 13, 2014

    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·May 3, 2022

    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

    FDA Recall
    Completed ·Illumina, Inc.·Product code PFF·April 5, 2023

    Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.

    FDA Recall
    Terminated ·Mallinckrodt Inc·Product code DXT·August 24, 2007

    Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013