title: In vitro diagnostic company recalls and medical laboratory practices: an Italian case.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Lima-Oliveira
authors.affiliation: Laboratory of Clinical Chemistry and Hematology, Academic Hospital of Parma, Parma, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
authors.affiliation: Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy.
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: Salvagno
authors.affiliation: Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Brocco
authors.affiliation: Laboratory of Clinical Biochemistry, Department of Life and Reproduction Sciences, University of Verona, Italy.
authors.forename: Gian Cesare
authors.initials: GC
authors.lastname: Guidi
mesh_terms: D019411:Clinical Laboratory Techniques; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D010281:Parathyroid Hormone; D057051:Product Recalls and Withdrawals; D011933:Reagent Kits, Diagnostic
chemical_list: D010281:Parathyroid Hormone; D011933:Reagent Kits, Diagnostic
keywords: clinical laboratory techniques; laboratory variability; parathyroid hormone; patient safety; quality control; reference standards