The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2637-2014·Announced 2014-09-24

Data Innovations Recalls ProVue Instrument Driver for JResultNet Software

Data Innovations, LLC is recalling ProVue Instrument Driver for JResultNet versions 1.5.3 and below because the software may misassociate data with patient results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that may cause data misassociation with patient results, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Data Innovations, LLC is recalling 84 units of the ProVue Instrument Driver for JResultNet (ProVue.jrm) versions 1.5.3 and below. The affected software is a stand-alone package that provides connectivity between in-vitro diagnostic instruments and Laboratory Information Systems to manage the flow of laboratory information, including test orders, results, specimen information, and patient information.

The recall was initiated because 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. The affected versions include releases from 1.0.0 through 1.5.3, with release dates ranging from June 17, 2004, to January 12, 2011.

The product was distributed nationwide, including in Alabama, Arizona, California, Connecticut, the District of Columbia, Florida, Georgia, Indiana, Louisiana, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Washington. The source text does not specify specific actions for consumers or healthcare providers to take.

The recalled product

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…
Manufacturer
Data Innovations, LLC
Category
Medical Device — Laboratory Software
Hazard
Affected units
84

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

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