VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics…

Date posted by the FDA

March 26, 2012

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems.

Reason

Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.

Distribution pattern

Worldwide Distribution

Quantity

120,225 of 60-slide count, 11.364 of 18-slide count

Codes and lots

all lots

Recall started

Feb. 2, 2012

Device type

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Root cause (FDA)

Device Design

What the company told customers

Ortho Clinical Diagnostics sent an Important Product Information letter dated February 2, 2012, to all affected customers via Federal Express overnight mail. The letter informed customers of the issue, notifying them of the removal of EDTA plasma as a recommended sample type and providing the revised VITROS dHDL Slides Instructions for Use. J&J Foreign affiliate consignees were notified by email informing them of the issue on 02 February 2012. Customers were instructed to replace the current pages in their VITROS Chemistry Products Instructions for Use Manual with the updated instructions for Use and Table of Contents. Customers were asked to return the enclosed Confirmation of Receipt form regardless of whether their laboratory uses the affected product. For any questions regarding this recall call 1-800-421-3311.

Recall number

Z-1316-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1316-2012. The agency record governs; check it and the company before acting.