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Sunquest Information Systems, Inc. recalls Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Recalled August 22, 2012 · FDA recall Z-2216-2012 · Sunquest Information Systems
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 · FDA Class III
Units
103 sites
Sold at
Nationwide Distribution
Description
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
Product
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Manufacturer(s)
Sunquest Information Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →