—#71772

Product

Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.

FDA product code: MRR — System, Test, Low Density, Lipoprotein
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K012287
Affected lot / code info: Lot 69740501.

Why it was recalled

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-06-11
Posted by FDA: 2008-10-09
Terminated: 2009-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71772. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.