Z-2569-2025Class II

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN)...

Name: Z-2569-2025 MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN)...
Creator: Medical Information Technology, Inc.
Published: 2025-02-05
License: https://open.fda.gov/license/

Medical Information Technology, Inc. / initiated 2025-02-05 / Open, Classified / root cause: software

FDA source

Medical Information Technology, Inc. began a recall of MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use on 2025-02-05. FDA classified it as Class II and gives the reason as "Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2569-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-05
Posted: 2025-09-16
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified via Salesforce email of this recall issue and provided instructions on workarounds
Quantity in commerce: 148 units
Distribution: Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom.
Product codes and lots: Software Release: 2.1, 2.2 (using the Web Presentation Layer); UDI: 00863529000155.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2569-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2569-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-16

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)