Z-2637-2014Class II

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

Name: Z-2637-2014 ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software...
Creator: Data Innovations, LLC
Published: 2014-08-15
License: https://open.fda.gov/license/

Data Innovations, LLC / initiated 2014-08-15 / Terminated / root cause: software

FDA source

Data Innovations, LLC began a recall of ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between... on 2014-08-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2637-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-15
Posted: 2014-09-12
Terminated: 2015-03-04
Recalling firm: Data Innovations, LLC
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Data Innovations LLC sent an Important Medical Device Information letter on August 15, 2014, to consignees for the JResultNet using ProVue Instrument Driver JResultNet (provue.jrm) v. 1.5.3 and below. Potential issues with the ProVue driver have been identified which may cause data to be mis-associated with patient results under a given set of circumstances. The user on the ProVue transmits the same results twice back to back by clicking the Send to Host button twice. The ProVue sends two ASTM messages back to back before ending transmission (sending an EOT character) The solution was to disconnect JResultNet from the ProVue instrument and apply the patch to driver provue.jrm when it is available. If you have further questions regarding this notice, please feel free to contact us at [email protected] or 239-931-6004 Toll-Free (from the US and Canada): 1-800-332-0499.
Quantity in commerce: 84
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2637-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2637-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)