FDAHealthFebruary 5, 2025

Medical Information Technology, Inc. — MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

⚠️ Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: February 5, 2025

Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.

What's affected?

Product: MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Brand: Medical Information Technology, Inc.
Lot code: Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 148 units.

View original FDA notice →

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