Recalls / —
—#83820
Product
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.
- FDA product code
- GJS — Test, Time, Prothrombin
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K071041
- Affected lot / code info
- All serial numbers.
Why it was recalled
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Roche Diagnostics Operations, inc.
- Address
- 9115 Hague Rd, Indianapolis, Indiana 46256-1025
Distribution
- Distribution pattern
- Worldwide Distribution
Timeline
- Recall initiated
- 2009-07-22
- Posted by FDA
- 2009-09-03
- Terminated
- 2011-04-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #83820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.