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ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Recalled August 16, 2023 · FDA recall Z-2357-2023 · ORTHO-CLINICAL DIAGNOSTICS
Hazard
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. · FDA Class II
Units
4,013 units
Sold at
Worldwide distribution - US Nationwide and the country of Canada.
Description
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Product
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Manufacturer(s)
ORTHO-CLINICAL DIAGNOSTICS
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →