Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche… recallZ-2003-2009 · Roche Diagnostics Operations, inc. · initiated Jul 22, 2009
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2003-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 22, 2009
- Posted by the FDA
- Sep 3, 2009
- Recalling firm
- Roche Diagnostics Operations, inc.
- Quantity
- 27,784 in US
- Product code
- GJS
- FDA submissions
- K062925
- Distribution
- Worldwide Distribution
Product description
Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
Code information (models, lots, serial numbers)
All serial numbers.
Other devices under the same FDA submission
3 devices cleared under K062925 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- COAGUCHEK XS PT TEST 6 STRIP 4625374160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN3 deaths1,681 reports
- CoaguChek XS Patient Self Testing Care Kit 03666794001Roche Diagnostics GmbH · Test, Time, Prothrombin212 reports
- CoaguChek XS Patient Self Testing Care Kit 4837738001Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN134 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 52724).
- Z-2002-2009 · TerminatedRoche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus Sy…
- Z-2004-2009 · TerminatedRoche 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…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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