Device product

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

Z-0476-2019

October 08, 2018

Class II

Product summary

Firm: Ortho-Clinical Diagnostics
Event: Event 81376
Status: Terminated
Classification: Class II
Quantity: 5850 units
Official record key: device-enforcement:Z-0476-2019

Official wording

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

Code information: Lot Numbers: 1517-26-6396 (expires 6-Nov-2018) 1517-26-6582 (expires 2-Feb-2019) 1517-26-6639 (expires 2-Feb-2019) 1517-27-6808 (expires 7-May-2019)

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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