Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 0
FDA device recall Z-0008-2009 · posted 2008-10-09 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 1068
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-06-11
- Date posted
- 2008-10-09
- Date terminated
- 2009-09-22
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA CREATININE PLUS VER.2 ASSAY (K024098) | Roche Diagnostics Corp. | 2002-12-19 |