Medical Information Technology, Inc. recalls MEDITECH Expanse Laboratory (LAB)
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical useUDIUDI 00863529000155.
What the firm is doing
Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2569-2025
- FDA device classification · JQPOfficial FDA classification for this device type
- CFR regulation · 21 CFR 862.2100The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medical Information Technology, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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