BEUDAMED
    52 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: Open, Classified ×

    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

    REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code GKZ·June 3, 2025

    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

    UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code GKZ·August 13, 2025

    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·January 20, 2022

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Biosciences·Product code GKZ·October 3, 2022

    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code GKZ·March 5, 2021

    Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·September 18, 2025

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·May 13, 2024

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code GKZ·July 8, 2025

    REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.

    FDA Recall
    Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code GKZ·June 3, 2025

    Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·June 14, 2022

    UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code GKZ·August 13, 2025