[Recalled] Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. — Online calculations may not be performed as expected or may yield results that… | FDA 2011-11-15

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.

This Class III 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 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 Laboratory LabAccess Results Workstation (LARS) — 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.