[Recalled] Sunquest Laboratory LabAccess Results Workstation (LARS) — The recall was initiated because Sunquest has confirmed that the Sunquest Labor… | FDA 2010-10-05

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.

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.

• Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. — Class III
• Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use — Class III
• Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry — Class II
• Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. — Class III
• 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 — Class II

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.