FDA Medical devices recall ·
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC)… recall
- Recall number
- Z-2569-2025
- Date
- (initiated February 5, 2025)
- Company / brand
- Medical Information Technology, Inc.
7 Blue Hill River Rd, Canton, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 148 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Why was it recalled?
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.
Distribution
Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2569-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.