Ortho-Clinical Diagnostics: Medical Device Recall in 2018 - (Recall #: Z-0476-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 8, 2018

Date Posted: November 28, 2018

Recall Number: Z-0476-2019

Event ID: 81376

Reason for Recall:

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

Status: Terminated

Product Quantity: 5850 units

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

Voluntary or Mandated:

Voluntary: Firm initiated