ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- Recall date
- June 5, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2357-2023
- FDA classification
- Class II
- Brand / firm
- ORTHO-CLINICAL DIAGNOSTICS
- Sold / distributed
- Worldwide distribution - US Nationwide and the country of Canada.
Why it was recalled
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
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