MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
This recall is currently active, issued September 16, 2025. It was issued by Medical Information Technology, Inc..
- Recall Initiated
- February 5, 2025
- Posted
- September 16, 2025
- Recall Number
- Z-2569-2025
- Quantity
- 148 units
- Firm Location
- Canton, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.
Root Cause
Software design
Action Taken
Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds