BEUDAMED
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    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 26, 2020

    Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·February 17, 2021

    CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·December 7, 2022

    CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·October 27, 2022

    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·July 17, 2020

    Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·December 22, 2020

    CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·May 17, 2021

    BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code MVU·July 17, 2015

    The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LDT·June 27, 2016

    OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.

    FDA Recall
    Terminated ·Celera Corporation·Product code LDT·July 12, 2013

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Dako North America Inc.·Product code LDT·September 4, 2015

    IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LDT·August 24, 2010

    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.

    FDA Recall
    Terminated ·Dako Denmark A/S Produktionsvej 42 Glostrup Denmark·Product code LDT·July 6, 2016

    NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code LDT·July 8, 2016

    Misys Laboratory versions 5.2, 5.23, or 5.3 with ADT Interface to CoPathPlus.

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·October 24, 2002

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·June 28, 2017

    Merge PACS software. The firm name on the label is Merge Healthcare.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 15, 2017

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018

    LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Distributed by Siemens, Concord, CA Mfg by Impac Medical Systems, Sunnyvale, CA Electronic patient records management system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LMB·March 23, 2011