Reported Aug 29, 2012 · Terminated

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

Sunquest Information Systems, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sunquest Information Systems, Inc. · 250 S Williams Blvd · Tucson, AZ · 85711-4472

Is this the product you have?

  • Sunquest Laboratory SMART & Sunquest
  • Laboratory SMART Select Product Usagefor clinical use
Lot codes and dates
  • Version 6.4.2
Amount recalled
47 sites

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was 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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 4, 2012 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.