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.

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

De Souza Lima Oliveira, Gabriel;LIPPI, Giuseppe;SALVAGNO, GIAN LUCA;BROCCO, GIORGIO;
2015-01-01

Abstract

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.
clinical laboratory techniques; laboratory variability; parathyroid hormone; patient safety; quality control; reference standards; False Positive Reactions; Female; Humans; Italy; Male; Clinical Laboratory Techniques; Parathyroid Hormone; Product Recalls and Withdrawals; Reagent Kits, Diagnostic
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/927567
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