Sunquest Laboratory, version 7.0 not available

FDA Recall #Z-0250-2013 — Class II — November 3, 2011

Recall #Z-0250-2013 Date: November 3, 2011 Classification: Class II Status: Terminated

Product Description

Sunquest Laboratory, version 7.0 not available

Reason for Recall

Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

Recalling Firm

Sunquest Information Systems, Inc. — Tucson, AZ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

14 sites

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Ireland

Code Information

not available

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated