Recall Z-0250-2013 ยท JQP Calculator/Data Processing Module, For Clinical Use
Sunquest Information Systems, Inc.
Sunquest Laboratory, version 7.0 not available
| Date | Nov 6, 2012 (initiated Nov 3, 2011) |
| Status | Terminated |
| Reason | Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data. |
| Root cause | Software design |
| Action | Sunquest Information Systems, Inc. sent a recall letter dated November 3, 2011, to all affected customers. Customers were informed of the problem identified and the actions to be taken. Customers were informed that a change request CR11-00174907 has been created to address this issue. This will be available as part of Sunquest Laboratory version 7.0.1. To request the software correction, customers were instructed to create a Case via the Client Support webpage at www.sunquestinfo.com/supportweb. Then choose a new case, and finally select work queue and select software request. Customers |
| Quantity | 14 sites |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.