Coaguchek Xs System

510(k) K062925

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK062925	Date29 Jan 2007Cleared	StatusActive

4 recalls · FDA

- Terminated Z-0804-2021 FDA Class II initiated 2 Dec 2020
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
- Terminated Z-1581-2013 FDA Class II initiated 16 May 2013
Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.
- Terminated Z-2003-2009 FDA Unclassified (pre-2012) initiated 22 Jul 2009
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
- Terminated Z-1594-2009 FDA Unclassified (pre-2012) initiated 13 May 2009
The lancet cap may be missing, which could result in an unintended lancet stick to the user.

1 jurisdiction

United States — FDA 510(k) Active

510(k)