Reported Sep 24, 2014 · Terminated

ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package…

Data Innovations, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Data Innovations, LLC · 2914 Cleveland Ave · Fort Myers, FL · 33901-6003

Is this the product you have?

  • 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.
Lot codes and dates
    • Version #s: 1.0.0 Date Released 6/17/2004
    • 1.0.1 Date Released 8/18/2004
    • 1.1.1 Date Released 9/9/2004
    • 1.2.0 Date Released 10/11/2004
    • 1.3.0 Date Released 11/1/2004
    • 1.3.1 Date Released 1/20/2005
    • 1.3.2 Date Released 2/18/2005
    • 1.4.0 Date Released 3/30/2005
    • 1.4.1 Date Released 8/31/2005
    • 1.4.2 Date Released 9/12/2005
    • 1.4.2 Date Released 10/5/2005
    • 1.4.3 Date Released 2/8/2006
    • 1.4.4 Date Released 2/20/2006
    • 1.4.5 Date Released 3/3/2006
    • 1.4.5 Date Released 3/23/2006
    • 1.4.5 Date Released 5/17/2006
    • 1.5.0 Date Released 6/26/2007
    • 1.5.1 Date Released 9/17/2007
    • 1.5.1 Date Released 12/13/2007
    • 1.5.1 Date Released 11/7/2008
    • 1.5.2 Date Released 4/13/2009
    • 1.5.3 Date Released 1/12/2011
Amount recalled
84

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 4, 2015 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.