ClearanceBrief
Recall Z-2569-2025 ยท JQP Calculator/Data Processing Module, For Clinical Use

Medical Information Technology, Inc.

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

DateSep 16, 2025 (initiated Feb 5, 2025)
StatusOpen, Classified
ReasonEntering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Root causeSoftware design
ActionConsignees were notified via Salesforce email of this recall issue and provided instructions on workarounds
Quantity148 units
DistributionWorldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.