Roche recalls CoaguChek XS PST Meters for possible misinterpretation of blood clotting results, affecting patients using anticoagulants. Ensure your meter displays INR results correctly.
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 CoaguChek XS PST Meters that may show incorrect blood clotting measurements. This could lead to improper medication dosing for people on anticoagulants like warfarin.
The meters might display blood clotting results in the wrong units (like %Quick or seconds instead of INR). This could cause incorrect medication dosing if users don't follow the instructions to ensure the device shows INR results.
Patients using CoaguChek XS PST Meters for blood clotting tests while on anticoagulants such as warfar:in or Coumadin. Those who rely on the device for accurate monitoring are most at risk.
The CoaguChek XS PST Meters are sold under catalog number 04837738001. All serial numbers are affected, so check your device's label for the catalog number or serial number.
Ensure the meter shows INR results by following the provided instructions. If it displays %Quick or seconds, contact Roche for guidance.
The meters may show blood clotting results in the wrong units (like %Quick or seconds instead of INR), which could lead to incorrect medication dosing.
All CoaguChek XS PST Meters with catalog number 04837738001 are affected. Check your device's label for the catalog number or serial number.
Ensure the meter displays INR results by following the instructions. If it shows %Quick or seconds, contact Roche for further guidance.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0804-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0804-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
