The initial reporter received questionable elecsys cea assay, and several other assay results from an unspecified number of patient samples tested on the cobas 6000 e601 (ul) v, with serial number (b)(4).The reporter stated, that the qc was out of range and multiple patient results were flagged.The reporter then ran an assay profile of the evening shift and noted, that the qc for cea was out of range twice.The procell and cleancell were then replaced.The qc was rerun with acceptable results.The reporter pulled an interface report and noticed several low results on multiple assays.The reporter was able to provide two examples of questionable results.The initial results were reported outside of the laboratory.Sample 1: on (b)(6) 2023, the initial result using an aliquoted sample was 63.46 ng/ml.On (b)(6) 2023, the repeat result using the primary tube (after service) was 118.9 ng/ml.Sample 2: the initial result was 0.5 ng/ml.The repeat result was 5.66 ng/ml.The repeat results were deemed correct. .
|