FDA Medical Device Recalls (openFDA)
Medical Information Technology, Inc.: MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
- Recall number
- Z-2569-2025
- Recalling firm
- Medical Information Technology, Inc.
- Product
- MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
- Status
- Open, Classified
- Initiated
- 2025-02-05
- Posted
- 2025-09-16
- Terminated
- not on file
- Reason
- Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
- Root cause
- Software design
- Action
- Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds
- Quantity
- 148 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
- Lot, serial or model codes
- Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3009404844
- Firm city
- Canton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28