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

Recall Z-2332-2012 — Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security

U.S. FDA — Device Enforcement · United States · 2012-03-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2332-2012
Date of alert: 2012-03-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sunquest Information Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event

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

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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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