Company: Dawning Technologies, Inc
Date of Enforcement Report: 9/24/2014
Class lI:
PRODUCT
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.
Recall Number Z-2637-2014
REASON
Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.
RECALLING FIRM/MANUFACTURER
Dawning Technologies, Inc., Fort Myers, FL on 8/15/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
84
DISTRIBUTION
Nationwide
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