SoftCytogenetics

Software is given wrong results going out to HIS on test that had reruns.

Dear SoftCytogentics Customer, The purpose of this letter is to advise you that SCC is voluntarily recalling SoftCytogenetics 4.1.11.20 and 4.1.12.11. There are software errors in these versions which SCC has designated to pose a potential risk-to-health issue. Reason for the Voluntary Recall: This task is to inform you of functionality in SoftCytogentics which SCC has designated to be a potential patient Risk-to-Health issue. For clients using Outbound Result Reporting with Resulting Profiles including Test Chapter macros, for cases that had multiple runs for reportable fields included to the Test Chapter macro, results from incorrect run may be sent outbound in HL7 message. Risk to Patient Care: When the results for test are processed with more than one run, and test uses the outbound reporting configuration of Resulting Profile* with Test Result macro added within, then some of results related to last reportable run can be sent outbound with values coming from any of the previous runs. These values are picked randomly from the previous runs. YOUR FACILITY DOES NOT CURRENTLY USE THIS CONFIGURATION. A hot fix would be required if you decide to implement this result reporting configuration prior to the next patch. Corrective Action: This issue will be corrected in the next software patch. Actions to be taken by the Customer/User: Please acknowledge receipt of this task and choose one of the following options: Workflow or functionality not used Agree to use alternative working solution Request hot fix if you decide to implement this result reporting configuration prior to the next patch.