Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number
FDA device recall Z-2002-2009 · posted 2009-09-03 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, inc.
- Reason for recall
- The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
- Action taken
- Roche Diagnostics Operations, Inc. notified Consignees by letter dated July 22, 2009 informing them of the problem and instructing them to use revised cleaning procedures. For further questions, contact Roche Diagnostics Operations, Inc. at 1-317-521-3194.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 37,215 in US
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-07-22
- Date posted
- 2009-09-03
- Date terminated
- 2011-04-27
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAGUCHEK XS SYSTEM (K060978) | Roche Diagnostics | 2006-08-11 |