Recall Z-0011-2009
Roche Diagnostics Corp. · initiated June 11, 2008
Product
Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of albumin concentration in serum and plasma.
Codes / lots: Lot 60087801.
Reason for recall
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
FDA-determined 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.
Details
- Recall number
- Z-0011-2009
- Initiated
- June 11, 2008
- Posted by FDA
- October 9, 2008
- Terminated
- September 22, 2009
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Quantity
- 124
- Distribution
- Nationwide Distribution
- Recalling firm
- Roche Diagnostics Corp., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0006-2009 | Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | 06/11/2008Terminated |
| Z-0007-2009 | Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | 06/11/2008Terminated |
| Z-0008-2009 | Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | 06/11/2008Terminated |
| Z-0009-2009 | Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | 06/11/2008Terminated |
| Z-0010-2009 | Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | 06/11/2008Terminated |
| Z-0012-2009 | Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics…Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. | 06/11/2008Terminated |