FDAFDA · Food and drugs·Recall number Z-0073-2013
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Published October 24, 2012 · Recall initiated: November 15, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sunquest Information Systems, Inc.
- Distributor
- Nationwide distribution
- Lot
- Versions 6.4.0 and later
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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