Reported Oct 24, 2012 · Terminated

Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

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 Laboratoryintended for use by professionals working in a clinical laboratory
Lot codes and dates
  • Versions 6.4.0 and later
Amount recalled
127 sites

Where it was sold

  • Nationwide

Why it was recalled

Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.

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 Oct 19, 2012 · Data as of Sep 19, 6:51 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.