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COmplaint conclusion
Nov 24, 2025 05:32 PM
Hi Nilay,
Our team has completed the review from the manufacturing of the current lots you have. Everything checked out as far as paperwork, calibration, calculations etc. There was no indication of nonconformance in any of our processes.
Our team did note that we typically use a methanol dispenser for dilutions, and because of the low concentrations on these products, multiple dilutions occurred for each analyte. It’s possible that the variability that can occur when using the dispenser could lead to the error rates reported. For your recent reorder, and any future lots we are changing our process to do all these dilutions by pipette which has tighter tolerances which we believe will result in a more accurate method. Please let me know if you have any questions or concerns.
Thank you,