Roche Diagnostics Operations, inc. Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
Brand
Roche Diagnostics Operations, inc.
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
Roche Diagnostics Operations, inc. is recalling Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; due to The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026