FDAClass IIIAugust 29, 2012

Sunquest Laboratory SMART & Sunquest Laboratory SMART recall

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

Why was Sunquest Laboratory SMART & Sunquest Laboratory SMART recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Version 6.4.2

Product
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Recalling firm
Sunquest Information Systems, Inc.
Quantity
47 sites
Distribution
US Nationwide Distribution
Recall date
August 29, 2012
Classification
Class III
Status
Terminated
Agency
FDA (device)
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