BEUDAMED
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    Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C Single User 1-year Educational License C10580 - Kaluza C 10 User Network Educational License C10581 - Kaluza C 5 User Network Educational License and C21166 - Kaluza C Program DVD v1.0

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JQP·June 23, 2021

    BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    cobas infinity central lab, Material Number 07154003001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JQP·December 12, 2022

    BD Synapsys Informatics Solution, Catalog Number 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·June 8, 2023

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    FDA Recall
    Open, Classified ·Medical Information Technology, Inc.·Product code JQP·February 5, 2025

    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·September 12, 2024

    BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JQP·November 9, 2018

    BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·September 23, 2025

    REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing, archiving and restoration of patient results.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JQP·April 8, 2025

    TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.

    FDA Recall
    Open, Classified ·Technidata S.A. 387 Avenue Jean Kuntzmann Montbonnot St Martin France·Product code JQP·March 27, 2023

    Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP SPT·Product code OJG·June 6, 2022

    Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.

    FDA Recall
    Open, Classified ·Accora Inc·Product code INM·June 21, 2021

    Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

    FDA Recall
    Open, Classified ·Accriva Diagnostics, Inc.·Product code JBP·November 5, 2025

    Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code JBP·October 20, 2025