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RecallWatchMedical Device Safety
Class IIOngoingZ-2569-2025

Medical Information Technology, Inc. recalls MEDITECH Expanse Laboratory (LAB)

Medical Information Technology, Inc.Canton, MA, United StatesReported Sep 24, 2025 · 9 months ago
Legal News Analyst ·

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 useUDI
    UDI 00863529000155.

What the firm is doing

Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds

DistributionShow details

Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

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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