Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
FDA Recall #Z-0073-2013 — Class III — November 15, 2011
Product Description
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Reason for Recall
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.
Recalling Firm
Sunquest Information Systems, Inc. — Tucson, AZ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
127 sites
Distribution
Nationwide distribution
Code Information
Versions 6.4.0 and later
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated