Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Published August 22, 2012 · Recall initiated: April 28, 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
In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Sunquest Information Systems, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Version 6.3.0 and Later
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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