Class 2 Device Recall MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN)

• Date Initiated by Firm: February 05, 2025
• Date Posted: September 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2569-2025
• Recall Event ID: 97455
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
• Code Information: Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.
• Recalling Firm/ Manufacturer: Medical Information Technology, Inc.; 7 Blue Hill River Rd; Canton MA 02021-1001
• For Additional Information Contact: Mike Hoachella; 781-821-3000
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds
• Quantity in Commerce: 148 units
• Distribution: Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.