Z-0010-2009

Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche...

Name: Z-0010-2009 Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche...
Creator: Roche Diagnostics Corp.
Published: 2008-06-11
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2008-06-11 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corp. began a recall of Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro... on 2008-06-11. The reason FDA records is "Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0010-2009
Status: Terminated
Initiated: 2008-06-11
Posted: 2008-10-09
Terminated: 2009-09-22
Recalling firm: Roche Diagnostics GmbH
Product: Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Product code: LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Reason for recall: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Consignees were notified via an Urgent Medical Device correction letter dated 6/11/08 informing users of the problem and providing them with work-around instructions. The instructions suggests 1) inserting the cassette rack slowly; 2) using mainly reagent slots A, B, or C; 3) tilting the rack slightly clockwise so the barcode scanner does not read the barcode at an exact 90 degree angle; and 4) confirming the rack is properly seated on the track and displayed on the Cassette Status screen. If the cassette barcode does not register after following the Work-Around instructions, then customers are required to contact Diagnostics Technical Support.
Quantity in commerce: 1245
Distribution: Nationwide Distribution
Product codes and lots: Lot 69535801.

Product code LBS

K012286Class IModification To:cobas Integra Hdl-Cholesterol Plus 2Nd GenerationRoche Diagnostics Corp. / cleared 2001-08-08

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)