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Ortho-Clinical Diagnostics recalls VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDL
Recalled November 28, 2018 · FDA recall Z-0476-2019 · Ortho-Clinical Diagnostics
Hazard
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results · FDA Class II
Units
5850 units
Sold at
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
Description
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
Product
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →