BEUDAMED
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    Lunar iDXA bone densitometer

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KGI·December 3, 2019

    Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KGI·December 3, 2019

    Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KGI·December 3, 2019

    Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code KGI·December 3, 2019

    Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 2-8-218 ASSY HOOKUP OLY 2K 2-8-236 ASSY, HOOKUP FUJINON 2K 2-8-244 ASSY, HOOKUP, STORZ 2K 2-8-245 ASSY, HOOK-UP, STORZ 2K 2-8-246 ASSY, HKUP, PENTAX-2K 2-8-260 ASSY, HOOK-UP WOLF 2-K 2-8-280 ASSY HOOKUP 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 2-8-330 ASSY, HOOK-UP, PENTAX-3K 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 2-8-336 ASSY,HKUP FUJI 70 BRONC 2-8-338 ASSY, HU, FUJI BRONCH U/S 2-8-421 ASSY, HOOKUP, FUJIFILM 2-8-428 ASSY, ED-580XX 2-8-431 ASSY, HOOKUP, PENTAX 2-8-432 ASSY, HOOK-UP, PENTAX 2-8-460 HOOKUP, ASSY WOLF 4K 2-8-511 ASSY, HOOK-UP, OLY 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 2-8-522 ASSY, FUJINON 4K-JET 2-8-523 ASSY, HKUP, FUJI 4K SER 5 2-8-526 ASSY, HOOKUP FUJI 4K+JET 2-8-527 ASSY, FUJI 700 NO FWJ 2-8-528 HOOK, EI-580BT 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 2-8-537 ASSY, HKUP, PTX90 4K+JET 2-8-539 HOOK, PTX I20 FWJ 2-8-540 ASSY-HOOK-UP,STORZ,5K 2-8-611 ASSY, HOOK-UP, OLY 2-8-612 ASSY, HOOKUP, PENTAX 2-8-614 ASM HU OLY TGF-UC180J 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 2-8-625 ASSY, HOOKUP, EG-580UT 2-8-626 ASSY, HOOKUP, EG-580UR 2-8-627 ASSY, HKUP, FUJI 700 SER 2-8-634 ASSY, HOOKUP PENTAX DUAL 2-8-639 HOOK, EG3X-J10 2-8-640 ASSY,HOOK-UP STORZ 6K 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 2-8-718 ASSY, HOOKUP, OLY 160/180 2-8-740 ASSY, HOOK-UP, STORZ 2-8-811 ASSY HKUP OLY-ECHO+LIFT 2-8-901 KIT TEE/TOE/RUS HU ADV+ 5-8-010 ASSY, HOOKUP DBL LT 5-8-030 ASSY, HOOKUP 5-8-040 ASSY HOOKUP STORZ 0K DBL 5-8-050 ASSY, HOOKUP, DILATOR 5-8-112 HOOKUP 2-SCOPE 1-K 5-8-190 HOOK DBL, IS, ION 5-8-210 ASSY, HOOKUP 5-8-245 HOOKUP KARLSTORZ-2K 2-8-001HAN HU ZERO CHANNEL NO LT 2-8-002HAN ADVANTAGE TEST BLOCK 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 2-8-160HAN ASSY, ADV HOOKUP, WOLF 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K 2-8-218HAN ASSY HOOKUP OLY 2K 2-8-245HAN ASSY, HOOKUP, STORZ-2K 2-8-330HAN ASSY, HOOK-UP, PENTAX-3K 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 2-8-335HAN ASSY,HOOKUP,OLYMPUS 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 2-8-421HAN ASSY, HOOKUP, FUJINON 2-8-428CAS HOOK, CAS, ED-580XX 2-8-428HAN HOOK, HAN, ED-580XX 2-8-431CAS ASSY, CASSETTE, PENTAX 2-8-431HAN ASSY, HOOK-UP, PENTAX 2-8-511HAN ASSY, HOOK-UP, OLY 2-8-526HAN ASSY, HOOKUP FUJI 4K+JET 2-8-536HAN HOOKUP,PENTAX,70ULT, 5K 2-8-537CAS ASSY,CASS,PTX 90 4K+JET 2-8-537HAN ASSY HKUP,PTX90 4K+JET 2-8-611HAN ASSY, HOOK-UP, OLY 2-8-626CAS ASSY, CASS, FUJINON 580UR 2-8-627HAN ASSY, HAN, FUJI 700 SER 2-8-634CAS ASSY,CASS PENTAX DUAL CH 2-8-634HAN ASSY,HOOKUP PENTAX DUAL 2-8-640HAN ASSY, HOOK-UP STORZ 6K 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K 2-8-718HAN ASSY,HOOK-UP, OLY 160/180 2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT 2-8-902H HU BLOCK ULTRASOUND PROBE 5-8-030HAN ASSY, HOOKUP 5-8-050HAN ASSY,HOOKUP, DILATOR 5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K 5-8-244HAN ASSY, HKUP 2K DBL

    FDA Recall
    Open, Classified ·Steris Corporation·Product code FEB·November 13, 2023

    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