Review article

https://doi.org/10.11613/BM.2015.028

In vitro diagnostic company recalls and medical laboratory practices: an Italian case

Gabriel Lima-Oliveira orcid.org/0000-0002-5937-9137 ; Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy
Giuseppe Lippi ; Laboratory of Clinical Chemistry and Hematology, Academic Hospital of Parma, Parma, Italy
Gian Luca Salvagno ; Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy
Giorgio Brocco ; Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy
Gian Cesare Guidi ; Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy

Abstract

Introduction: In vitro human diagnostic (IVD) company recalls are a common practice aimed to either minimize a potential error or eliminate an existing failure. In this case report, we aim to provide a critical analysis of a recent IVD recall and to provide a practical framework about what to do when an IVD company recalls product(s) based on the International Organization for Standardization - ISO 15189:2012 standard.
Case report: In 2014, Abbott Laboratories® (Green Oaks, IL) published an urgent field safety notice regarding a product recall (Architect Intact parathyroid hormone (PTH) Assay List Number 8K25) with immediate action required. The IVD company explained the reasons for the recall as follows: i) Abbott has confirmed that a performance shift in the Architect Intact PTH assay has the potential to generate falsely elevated results on patient samples; ii) results generated with impacted lots may demonstrate a positive shift relative to those generated with previous reagent and/or calibrator lots. This issue may also impact established Architect Intact PTH reference ranges; iii) the magnitude of shift averages approximately 13% to 45%; iv) Abbott Architect Intact PTH controls do not detect the shift; and v) all current reagent, calibrator, and control inventory are impacted. The recall could have resulted in ~40,000 inaccurate laboratory tests reported by 18 laboratories from Italy (Lombardy region).
Conclusion: IVD company recalls have a serious impact on the patient safety and require a thorough investigation and responsible approach to minimize the possible damage. Medical laboratories accredited according to the ISO 15189 standard have procedures in place to manage such situations and ensure that patient safety is maintained when such recalls are issued

Keywords

clinical laboratory techniques; patient safety; laboratory variability; reference standards; quality control; parathyroid hormone

Hrčak ID:

139814

URI

https://hrcak.srce.hr/139814

Publication date:

15.6.2015.

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