Recall Z-2216-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use
Sunquest Information Systems, Inc.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
| Date | Aug 16, 2012 (initiated Apr 28, 2011) |
| Status | Terminated |
| 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 (/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 |
| Root cause | Software design |
| Action | Sunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laborato |
| Quantity | 103 sites |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.