Food, drugs, devices › Medical Information Technology, Inc.
Device recall: MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data proce
FDA enforcement event 97455 is a device recall by Medical Information Technology, Inc. of Canton, MA, initiated 5 Feb 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medical Information Technology, Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medical Information Technology, Inc., Canton, MA.
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."
Distribution
"Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2569-2025 | MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use. | 148 units | Class II | Ongoing | 24 Sep 2025 |
Context
Other enforcement events for Medical Information Technology, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Feb 2014 | MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates req | Device | Class II | 1 |
| 17 Jan 2014 | MEDITECH Microbiology - Calculator/data processing module, for clinical use. | Device | Class II | 1 |
| 7 May 2013 | MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information | Device | Class II | 1 |
All 4 events for Medical Information Technology, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of British Virgin Islands, Canada, Ireland & United Kingdom."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.