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Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology

MEDICAL INFORMATION TECHNOLOGY, INC. · Model Expanse · UDI-DI 00863529000155

JQP
10
510(k) clearances
2,182
Adverse events (5 deaths)
220
Recalls
116
Facilities

Description

MEDITECH's Laboratory application closely integrates requisition, specimen processing, and patient information with data in Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry through seamless integration with laboratory instruments. Authorized users have the ability to view laboratory results via a specimen inquiry or a patient summary. MEDITECH's Genetics application closely integrates requisition, specimen processing, and patient information with data in an Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient collection of specimens, and result entry. Authorized users have the ability to view genetic test results via a specimen inquiry or a patient summary. MEDITECH's Microbiology application closely integrates requisition, specimen processing, and patient information with data in the Electronic Health Record (EHR). The application allows ordering of tests from multiple locations, efficient processing for collection and resulting of specimens including: bacteriology, mycology, parasitology, virology, and mycobacteriology. MEDITECH's Anatomical Pathology application automates the data handling needs of the Pathology department with features for recording, storing, coding, searching, and reporting Pathology cases. MEDITECH's EHR gives users the ability to view Radiology reports and lab results pertinent to the case, and to integrate relevant data into Pathology reports. Authorized users have the ability to view Anatomic Pathology results from within the network.

Recalls

DateFirmReason
2026-06-16Copan WASPDue to a software issue within the WebApp that potentially prevents the user to overwrite the results.
2026-04-29Beckman Coulter Biomedical GmbHDue to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting
2025-09-23Becton Dickinson & Co.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar
2025-04-08Beckman Coulter Inc.Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or
2025-02-05Medical Information Technology, Inc.Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv
2024-09-12Becton Dickinson & Co.Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoint

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.