Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of creatine in serum, urine 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-0008-2009
- Quantity
- 1068
- 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 60064001.
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.