Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders

U.S. FDA — Device Enforcement · United States · 2014-08-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2637-2014
Date of alert: 2014-08-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Data Innovations, LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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