Ortho-Clinical Diagnostics recalls VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LD…
- Recall date
- October 8, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0476-2019
- FDA classification
- Class II
- Brand / firm
- Ortho-Clinical Diagnostics
- Sold / distributed
- Nationwide Foreign: Australia Belgium Bermuda, HM11 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Poland Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
Why it was recalled
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased 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¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
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