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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