Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
This recall has been terminated (originally issued September 3, 2009).
- Recall Initiated
- July 22, 2009
- Posted
- September 3, 2009
- Terminated
- April 27, 2011
- Recall Number
- Z-2004-2009
- Quantity
- 1,327 in US
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
Distribution
Worldwide Distribution
Lot / Code Info
All serial numbers.
Root Cause
Device Design
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.
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