FDA-Device2023-08-16Class II
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
Hazard
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
4,013 units
Manufactured in
Felindre Meadows, N/A, Bridgend, N/A, United Kingdom
Products
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2023Don't want to check this manually?
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