Device product
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Z-2216-2012
Product summary
- Event
- Event 62344
- Status
- Terminated
- Classification
- Class III
- Quantity
- 103 sites
- Official record key
device-enforcement:Z-2216-2012
Official wording
Reason: 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
Code information: Version 6.3.0 and Later
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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