Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122.
FDA device recall Z-0007-2009 · 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
- JIY
- Quantity affected
- 523
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-06-11
- Date posted
- 2008-10-09
- Date terminated
- 2009-09-22
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES (K951595) | Roche Diagnostic Systems, Inc. | 1995-09-08 |