The initial reporter received questionable crep2 creatinine plus ver.2 results for multiple patient samples with the cobas 8000 cobas c 701 module serial number (b)(4) between (b)(6) 2021.The reporter stated the calibration looked different than other historical calibrations but was acceptable and qc was in range.Upon performing qc again, the reporter noticed a shift and decided to repeat a couple of patient samples and the results were not in agreement.The reporter then replaced the reagent pack, recalibrated and the calibration was typical of what was observed in the past.The reporter then repeated all samples tested between (b)(6) 2021.The following are examples of questionable results for 3 patient samples: sample id (b)(6).The initial result was 0.84 mg/dl.The repeated result was 1.06 mg/dl.Sample id (b)(6).The initial result was 0.91 mg/dl.The repeated result was 1.10 mg/dl.Sample id (b)(6).The initial result was 0.83 mg/dl.The repeated result was 1.03 mg/dl.The questionable results were reported outside of the laboratory.The repeated results were deemed correct and corrected reports were issued.
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