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Open, Classified

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

FDA Recall Z-2569-2025 · Posted 2025-09-16

Recall StatusOpen, Classified
Product CodeJQP
Date Initiated2025-02-05
Product Quantity148 units

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.

Firm Action

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

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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