FDA-Device2012-08-22Class III
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Sunquest Information Systems, Inc.
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
Sold states
Nationwide Distribution
Affected count
103 sites
Manufactured in
250 S Williams Blvd, Tucson, AZ, United States
Products
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2216-2012Don't want to check this manually?
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