Data Innovations—Instrument Manager Software Drivers Used with Siemens DPC Cirrus Immulite, Immulite, and VersaCell Systems: Quality Control Results May Be Filed Incorrectly

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In a June 29, 2016, Important Medical Device Recall Information letter submitted by an ECRI Institute member hospital, Data Innovations states that the above software drivers may cause quality control (QC) results without a QC specimen ID (SID) to be filed with patient results that follow on the same message on the above systems. Data Innovations further states that this can occur when the above systems are running in unidirectional mode and are configured to automatically send QC results to the laboratory information system (LIS). If the SIDs are not added to the QC samples, then QC results received by the above software without...