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[Recalled] 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 th

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductSunquest 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
Brand / manufacturerSunquest Information Systems, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2332-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date15 March 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Sunquest Information Systems, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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