FDA recall Z-2569-2025

Medical Information Technology, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-02-05
Report date
2025-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Canton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2569-2025