FDA recall Z-0476-2019

Product

VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)

Reason for recall

VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-10-08

Report date

2018-11-28

Termination date

2022-10-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0476-2019