BEUDAMED
    24 results · 12ms · 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 Status: Terminated ×

    Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440

    FDA Recall
    Terminated ·Clark Laboratories, Inc.·Product code MJH·October 11, 2021

    NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code MJH·September 29, 2006

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·July 22, 2015

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Recall
    Terminated ·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014

    AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJH·June 2, 2009

    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJH·March 3, 2016

    MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJH·May 2, 2018

    Kit BD Max ExK TNA 2; Catalog # 442825

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code JJH·July 23, 2018

    PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

    FDA Recall
    Terminated ·ABX Diagnostics Inc·Product code GJH·June 24, 2004

    Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.

    FDA Recall
    Terminated ·Merck Millipore Ltd. Tullagreen Carrigtwohill County Cork Ireland·Product code JJH·May 14, 2018

    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.

    FDA Recall
    Terminated ·Abbott Molecular·Product code JJH·December 4, 2012

    Kit BD Max ExK DNA 1 USA; Catalog # 442817

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·QIAGEN 19300 GERMANTOWN RD GERMANTOWN MD 20874 USA KOELN Germany·Product code JJH·May 28, 2018

    Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.

    FDA Recall
    Terminated ·Abbott Molecular·Product code JJH·October 23, 2014

    MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJH·November 25, 0013

    eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JJH·April 10, 2017

    Kit BD Max ExK DNA 2 USA; Catalog # 442819

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code JJH·June 5, 2019

    MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJH·June 3, 2020