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.
This recall has been terminated (originally issued October 9, 2008).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- June 11, 2008
- Posted
- October 9, 2008
- Terminated
- September 22, 2009
- Recall Number
- Z-0010-2009
- Quantity
- 1245
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
Distribution
Nationwide Distribution
Lot / Code Info
Lot 69535801.
Root Cause
Labeling Change Control
Action Taken
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.