VITROS® ECi Immunodiagnostic System - Troponin I Es Reagent Pack

Ortho Clinical Diagnostics (QuidelOrtho) became aware of an issue affecting VITROS® Immunodiagnostic products Troponin I Es Reagent Pack, lot 4800. Due to a manufacturing error, around 1% of reagent packs contain incorrect wells which will generate inaccurate results. During a review of manufacturing records, QuidelOrtho confirmed that 87 incorrect wells (0.022% of total wells produced) were included in the manufacture of VITROS® Troponin I Es Reagent Pack, lot 4800. If the affected wells are used for calibration, quality control testing, or sample testing, they will not produce the appropriate or expected signal levels. Please note that while a reagent pack may include multiple affected wells, not all wells within the reagent pack are affected.

Recall start date : June 7, 2023