Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2569-2025·Announced 2025-09-24

Laboratory information software recalled over data removed from first form field

MEDITECH Expanse Laboratory modules are recalled because entering multiple keys that trigger input simultaneously may remove data from the first field of screens or questionnaires. 148 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice describes a data entry behaviour without stating any patient consequence.

Plain-English summary

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH) and Genetics (GEN) modules, a calculator and data processing module for clinical use, UDI 00863529000155, are being recalled in software releases 2.1 and 2.2 using the Web Presentation Layer. The recall covers 148 units distributed in the United States and in the British Virgin Islands, Canada, Ireland and the United Kingdom.

Entering multiple keys that trigger input simultaneously may remove data from the first field of screens and/or questionnaires with more than one field. The FDA classified the action as Class II. The notice does not describe a further consequence.

Laboratories running these releases should follow the manufacturer's instructions for the software correction.

The recalled product

Product: MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Manufacturer: Medical Information Technology, Inc.
Category: Medical Device — Clinical Software
Hazard: software-defect
data-entry
class-ii
Affected units: 148

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Software Release: 2.1
2.2 (using the Web Presentation Layer)
UDI: 00863529000155.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medical Information Technology, Inc.

See all →

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FDA (Devices) · 2014-03-26
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Medical Information Technology Recalls MEDITECH Microbiology Calculator Module
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Medical Information Technology Recalls Bi-Directional Communication Analyzer Interface
FDA (Devices) · 2013-05-29

Same hazard · software defect