Recall Z-0476-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-0476-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-08

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2018-10-08, terminated 2022-10-13. It names one FDA 510(k) clearance: K041720. Product: VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793). Reason: VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2018-10-08
Terminated: 2022-10-13
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND IIOrtho-Clinical Diagnostics, Inc.·cleared 2004-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.