Medical Information Technology, Inc.
Canton, MA, US
Medical Information Technology, Inc. appears in FDA device records in Canton, MA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009404844 | 3009404844 | Medical Information Technology, Inc. | 7 Blue Hill River Rd, Canton, MA 02021 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2569-2025 | MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use. | Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field. | Class II | Open, Classified | |
| Z-1234-2014 | 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 requisition, specimen processing, and patient information with data in the healthcare information system (HCIS). | Potential for erroneous result reporting. | Class II | Terminated | |
| Z-1124-2014 | MEDITECH Microbiology - Calculator/data processing module, for clinical use. | Potential for patient results being removed from LAB/EMR. | Class II | Terminated | |
| Z-1365-2013 | MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information. | Incorrect transmission of laboratory results. | Class II | Terminated | |
| Z-1465-2012 | MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time. | Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain