FDA-Device2014-09-24Class II
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.
Data Innovations, LLC
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.
Sold states
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.
Affected count
84
Manufactured in
2914 Cleveland Ave, N/A, Fort Myers, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2637-2014Don't want to check this manually?
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