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Data Innovations, LLC recalls ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package
Recalled September 24, 2014 · FDA recall Z-2637-2014 · Data Innovations
Hazard
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. · FDA Class II
Units
84
Sold at
Nationwide Distribution including AL, AZ, CA, CT, DC, FL, GA, IN, LA, MI, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
Description
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.
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.
Manufacturer(s)
Data Innovations, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →