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    DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.

    FDA Recall
    Terminated ·Invivo Corporation·Product code LLZ·January 24, 2018

    DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·April 11, 2018

    Misys Laboratory version 5.3

    FDA Recall
    Terminated ·Sunquest Information Systems·Product code JQP·November 15, 2002

    Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JQP·October 25, 2007

    Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·August 8, 2011

    Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use. Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs.

    FDA Recall
    Terminated ·Microsoft Corporation Health Solutions Group·Product code JQP·April 12, 2012

    Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2.

    FDA Recall
    Terminated ·Cerner Corp·Product code JQP·January 19, 2009

    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

    FDA Recall
    Terminated ·PerkinElmer Health Sciences, Inc.·Product code JQP·June 27, 2014

    GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.

    FDA Recall
    Terminated ·GE Healthcare Integrated IT Solutions·Product code JQP·September 22, 2008

    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JQP·May 15, 2007

    Aqueduct Hematology Workflow Manager, software

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JQP·August 10, 2005

    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·October 17, 2011

    Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·April 13, 2009

    TD-Synergy. Laboratory Information System.

    FDA Recall
    Terminated ·Technidata S.A. 387, Avenue Jean Kuntzmannn Montbonnot St Martin France·Product code JQP·July 29, 2010

    MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JQP·November 3, 2015

    ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code JQP·October 30, 2014

    RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code JQP·March 9, 2022

    cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·July 15, 2016

    Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the label of an individual sample tube because the original label is deteriorated.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQP·May 24, 2018