Sunquest Laboratory LabAccess Results Workstation (LARS)

FDA Recall #Z-2272-2012 — Class II — October 5, 2010

Recall #Z-2272-2012 Date: October 5, 2010 Classification: Class II Status: Terminated

Product Description

Reason for Recall

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.

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

151 sites

Distribution

Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.

Code Information

Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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