MEDITECH Expanse Laboratory (LAB), Microbiology (MIC)… recallZ-2569-2025 · Medical Information Technology, Inc. · initiated Feb 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Information Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
FDA root cause category: Software design
What the company is doing
Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds
Recall details
- Recall number
- Z-2569-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 5, 2025
- Posted by the FDA
- Sep 16, 2025
- Recalling firm
- Medical Information Technology, Inc.
- Quantity
- 148 units
- Product code
- JQP
- Distribution
- Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
Product description
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Code information (models, lots, serial numbers)
Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Expanse Laboratory/Genetics/Microbiology/Anatomical PathologyMedical Information Technology, Inc. · Calculator/Data Processing Module, For Clinical Use1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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