FDA Medical Device Recalls (openFDA)
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 number
- Z-2002-2009
- Recalling firm
- Roche Diagnostics Operations, inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-07-22
- Posted
- 2009-09-03
- Terminated
- 2011-04-27
- Reason
- The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 37,215 in US
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K060978"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28