FDA (Devices) recall action 65246
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Roche is recalling CoaguChek XS Plus systems because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Roche is recalling 537 CoaguChek XS Pro Systems because they may display an error message instead of a prothrombin time value.
Roche is recalling CoaguChek XS meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Roche is recalling CoaguChek XS System meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.