Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
FDA Recall #Z-2229-2012 — Class III — August 12, 2011
Product Description
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Reason for Recall
In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
Recalling Firm
Sunquest Information Systems, Inc. — Tucson, AZ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
47 sites
Distribution
US Nationwide Distribution
Code Information
Version 6.4.2
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated