Expanse Laboratory/Genetics/Microbiology/Anatomical PathologyRecalls & reported problems
Medical Information Technology, Inc. · 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. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00863529000155), received between Nov 18, 2024 and Oct 27, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Transmit Record” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Feb 5, 2025Class IIOpen, Classified
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Z-2569-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Transmit Record1
- Improper or Incorrect Procedure or Method1
Patient problems
- Breast Mass1
- Sepsis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE REPORTED ADVERSE EVENT (AE) ORIGINATED AT (B)(6) AND CENTERED ON A PRODUCT USE ERROR THAT RESULTED IN A FIVE-MONTH DELAY IN A PATIENT'S LYMPHOMA DIAGNOSIS AND SUBSEQUENT REFERRAL TO MEDICAL ONCOLOGY. THE DELAY OCCURRED BECAUSE A PROVIDER MISSED CRITICAL DIAGNOSTIC INFORMATION. THE PATIENT, A 73-YEAR-OLD, HAD A LEFT BREAST MASTECTOMY ON (B)(6) 2025. THE PROBLEM THE CORE ISSUE WAS CONFUSION CAUSED BY BLANK PAGES IN AN OUTSIDE VENDOR (OV) PATHOLOGY REPORT (FROM (B)(6) CLINIC) THAT HAD BEEN IMPROPERLY COPIED INTO THE MEDICAL INFORMATION TECHNOLOGY, INC. (MEDITECH) ANATOMICAL PATHOLOGY (PTH) REPORT. IMPROPER WORKFLOW ON (B)(6) 2025, WHEN THE OV RESULTS WERE ENTERED, THE PROVIDER ATTACHED THE OV REPORT TO THE MEDITECH ANATOMICAL PATHOLOGY SPECIMEN REPORT BY TAKING A SCREENSHOT AND USING THE COPY/PASTE FUNCTION IN MICROSOFT WORD. RESULTING BLANK PAGES THIS FLAWED WORKFLOW RESULTED IN TWO PRIMARILY BLANK PAGES BEING INSERTED BETWEEN PAGES 1 AND 3 OF THE MAYO CLINIC PATHOLOGY REPORT WITHIN THE MEDITECH SYSTEM. THESE BLANK PAGES LATER CAUSED CONFUSION DURING CHART REVIEW. MISSED DIAGNOSIS THE PROVIDER REVIEWED ONLY THE FIRST PAGE, WHICH DISPLAYED A "RESULT SUMMARY" OF "NEGATIVE" FOR B-CE
Patient problems: Breast Mass
MAUDE report 23391290 ↗InjuryNov 18, 2024Failure to Transmit Record; Failure to Transmit Record
ON OCTOBER 23, 2024 A CUSTOMER REPORTED AN ADVERSE EVENT WHERE A PATIENT'S REPORT WAS NOT FAXED FROM THE LABORATORY TO THE ORDERING PROVIDER AFTER MICROBIOLOGY CULTURE RESULTS WERE VERIFIED. CONCERNS WERE RAISED ABOUT THE PATIENT'S ADMISSION TO THE HOSPITAL DUE TO SEPSIS. THE CUSTOMER ASSERTED THAT THE ADMISSION COULD HAVE BEEN AVOIDED IF THE PROVIDER HAD RECEIVED THE REPORT AND ADMINISTERED AN ANTIBIOTIC EFFECTIVE IN TREATING THE PATIENT'S ESCHERICHIA COLI (E. COLI) INFECTION.
Patient problems: Sepsis
MAUDE report 20706009 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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