Roche recalls professional CoaguChek XS Prof meters for possible misinterpretation of INR results as %Quick or seconds. Healthcare providers should verify display settings to avoid incorrect warfarin monitoring.
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
Roche is recalling professional CoaguChek XS Prof meters that might show warfarin test results incorrectly. This could lead to improper dosing of blood thinners if users don't check the display settings properly.
The meters might display results in %Quick or seconds instead of INR, which could cause incorrect warfarin dosing. This happens if the device isn't set to show INR results correctly.
Healthcare providers using CoaguChek XS Prof meters for warfarin monitoring. Those most at risk are clinicians who rely on these meters for accurate blood thinner dosing.
Check for CoaguChek XS Prof meters with catalog numbers 04837975001, 06298176001, 08468699001, 08468745001, or 08468753001. All units have serial numbers.
Ensure the meter shows INR results by following the manufacturer's instructions for correct display configuration.
No, but you should verify the display settings to ensure it shows INR results correctly.
Catalog numbers include 04837975001, 06298176001, 08468699001, 08468745001, and 08468753001.
Follow the manufacturer's instructions to confirm the meter is set to show INR results, not %Quick or seconds.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0803-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0803-2021 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
