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Vitros® eci immunodiagnostic system - troponin i es reagent pack
Official notice
22 Jun 2023
Last checked
22 Jun 2023
An official Health Canada notice concerns 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 Published 2023-06-22.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73864
Official notice
2023-06-22
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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The source does not list specific retailers. See the official notice for where affected products were sold.
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Brand: Ortho-clinical Diagnostics, Vitros® Eci Immunodiagnostic System - Troponin I Es Reagent Pack.
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Documents, notices & source
See the official notice and source documents for full details.
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