FDA-Device2018-11-28Class II
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Ortho-Clinical Diagnostics
Hazard
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
Sold states
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
Affected count
5850 units
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0476-2019Don't want to check this manually?
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