FDA (Devices) recall action 86951
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Roche is recalling CoaguChek XS PST meters because they may display blood-clotting results in the wrong units. Users should verify their meter is set to INR.
Roche is recalling CoaguChek XS Prof meters because they may display results in incorrect units, potentially leading to misinterpretation of warfarin monitoring data.