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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