Recall of ADVIA CENTAUR XPT INSTRUMENT

Recall

86117

II

2015-07-31

Canada

HC

1. the "reset ranges" button in the ranges window of a tdef currently does not properly reset predefined overdilution points. this impacts the assay thcg which has a predefined overdilution point. if the "reset ranges" button is pressed for thcg the assay will lose its predefined over dilution point and diluted results which are below the overdilution point will not be flagged as overdiluted. 2. if the system is set up to process samples with the settings for rack id positions mode and rack order mode activated at the same time the system will not process test orders if there are no sample identifiers (sid's) defined for the tubes. in addition when processing samples with these settings and a second rack is received for processing within 15-30 seconds of the ejection of the 1st rack the system may incorrectly use the orders of the 1st rack when processing the 2nd rack. this will cause transposition of patient results. the maintenance operation to automatically move completed test data to historical does not move sids associated with multiple assays to the historical database. for example if sid "xyz" had been run for tests afp and tsh that sid would not be moved to the historical database by the "move to historical" maintenance activity. 4. the visual status light currently does not light up for certain scenarios. the visual status light will not light up for unacknowledged warnings or errors associated with the following tabs: samples reagents calibrations and supplies. 5. the system may incorrectly use a primary reagent pack with a lower priority when a primary reagent pack with a higher priority is available. this may also result in the instrument using an uncalibrated primary pack if the assay has the "assign cal" parameter enabled within the tdef. since the reagent pack was un-calibrated the system will not generate results and will only report a relative light unit (rlu) value. 6. in the qc definition screen the system has a field for "+/- range". the system considers this parameter to be the 2 standard deviation (sd) range value. the qc definition fields are all handled by the system under the assumption that the values being entered are for a +/- 2sd range. if users are unaware of this they could enter in values associated with either a wider or smaller range and the instrument would be unaware. this can cause qc flagging to be incorrect. 7. when the system is configured to a date/time format other than english (united states) the date/time information for calibration events is not displayed in the quality control windows.