Cl ll Meditech interactive Communication Analyzer

Company: Medical Information Technology, Inc.
Date of Enforcement Report: 5/29/2013
Class ll:

PRODUCT

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.
Recall Number Z-1365-2013

REASON
Incorrect transmission of laboratory results.

RECALLING FIRM/MANUFACTURER
Medical Information Technology, Inc., Westwood, MA on 5/7/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
56 devices

DISTRIBUTION
Nationwide and Canada

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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