Z-1316-2012

VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg...

Name: Z-1316-2012 VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg...
Creator: Ortho-Clinical Diagnostics
Published: 2012-02-02
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-02-02 / Terminated / root cause: design

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc... on 2012-02-02. The reason FDA records is "Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1316-2012
Status: Terminated
Initiated: 2012-02-02
Posted: 2012-03-26
Terminated: 2018-07-05
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Reason for recall: Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 120,225 of 60-slide count, 11.364 of 18-slide count
Distribution: Worldwide Distribution
Product codes and lots: all lots

Product code LBS

K042006Class IVitros Chemistry Products Dhdl Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products PerformaceOrtho-Clinical Diagnostics, Inc. / cleared 2004-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)