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Licensed Unlicensed Requires Authentication Published by De Gruyter April 11, 2022

Unexpectedly low tacrolimus concentrations attributed to inappropriately labeled water container from the instrument manufacturer

Erik Ames and Raffick A.R. Bowen

Corresponding author: Raffick A.R. Bowen , Department of Pathology, Stanford University, 300 Pasteur Drive, Room H1401J, Stanford, CA 94305, USA, Phone: +1 650 736 8080, Fax: +1 650 724 6843, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

References

1. Bargnoux, AS, Sutra, T, Badiou, S, Kuster, N, Dupuy, AM, Mourad, G, et al.. Evaluation of the new Siemens tacrolimus assay on the dimension EXL integrated chemistry system analyzer: comparison with an ultra-performance liquid chromatography-tandem mass spectrometry method. Ther Drug Monit 2016;38:808–12. https://doi.org/10.1097/ftd.0000000000000331.Search in Google Scholar PubMed

2. Kalt, DA. Tacrolimus: a review of laboratory detection methods and indications for use. Lab Med 2017;48:e62–e65. https://doi.org/10.1093/labmed/lmx056.Search in Google Scholar PubMed

3. Clinical and Laboratory Standards Institute (CLSI). Preparation and testing of reagent water in the clinical laboratory; approved guideline. 4th ed. CLSI document GP40-A4-AMD. Clinical and Laboratory Standards Institute, Wayne, PA, 2012.Search in Google Scholar

4. Nabulsi, R, Al-Abbadi, MA. Review of the impact of water quality on reliable laboratory testing and correlation with purification techniques. Lab Med 2014;45:e159–65. https://doi.org/10.1309/lmlxnd0wnrjj6u7x.Search in Google Scholar PubMed

5. U.S. Food and Drug Administration. Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry. Available from: https://www.fda.gov/media/152208/download [Accessed 14 Feb 2022].Search in Google Scholar

6. U.S. Food and Drug Administration. Device Advice: Comprehensive Regulatory Assistance. Quality System Regulation Labeling Requirements. Available from: https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements [Accessed 14 Feb 2022].Search in Google Scholar

Received: 2022-03-05
Accepted: 2022-03-26
Published Online: 2022-04-11
Published in Print: 2022-06-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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