Medical device recalls Moderate risk

Medical Information Technology, Inc. recalls MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data proc…

Recall date
February 5, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2569-2025
FDA classification
Class II
Brand / firm
Medical Information Technology, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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