Alere recalls 800,000 Triage tests on quality control issues
This article was originally published in Clinica
Executive Summary
Alere has recalled 803,000 of its Triage tests after problems with quality control testing and performance of the diagnostics. The recall affects a total of 104 lots comprising 287,000 Alere Triage BNP (B-type natriuretic peptide) tests, 46,000 Alere Triage D-dimer tests and 470,000 Alere Triage cardiology panel tests, according to a company filing with the US Securities and Exchange Commission (SEC).