FDA Device recall Z-2637-2014
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connecti…
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connecti… by Data Innovations, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2637-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-15 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Data Innovations |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | 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 Rele…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2637-2014%22
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