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Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

FDA Recall #Z-2216-2012 — Class III — April 28, 2011

Recall #Z-2216-2012 Date: April 28, 2011 Classification: Class III Status: Terminated

Product Description

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Reason for Recall

In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or

Recalling Firm

Sunquest Information Systems, Inc. — Tucson, AZ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

103 sites

Distribution

Nationwide Distribution

Code Information

Version 6.3.0 and Later

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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