Roche recalls CoaguChek XS PT test strips with catalog numbers 04625315160, 04625374160, and 07797826160 due to abnormally high INR test results. Affected lots listed in the recall notice.
Abnormally high INR test results with the affected CoaguChek test strips
Roche is recalling CoaguChek XS PT test strips that may produce abnormally high INR results. This could lead to incorrect blood clotting assessments, potentially causing unsafe treatment decisions. Affected strips have specific catalog numbers and lot numbers listed in the recall notice.
The affected test strips may produce abnormally high INR results, which can lead to incorrect blood clotting assessments. This might cause unsafe treatment decisions if the results are used for medical decisions without correction.
People using CoaguChek XS PT test strips with catalog numbers 04625315160, 04625374160, or 07797826160 and the listed lot numbers are affected. Those with these specific test strips may get inaccurate blood clotting results.
Check the catalog number on the test strips. The affected catalog numbers are 04625315160, 04625374160, and 07797826160. Also check the lot numbers listed in the recall notice for the specific affected strips.
Look for the catalog number on the test strips to determine if they are affected.
Reach out to Roche Diagnostics Corporation for further assistance if you have the affected catalog numbers.
The affected test strips have catalog numbers 04625315160, 04625374160, and 07797826160 with specific lot numbers listed in the recall notice.
Check the catalog number on the test strips. If it matches 04625315160, 04625374160, or 07797826160 and the lot number is in the list provided, your strips are affected.
Contact Roche Diagnostics Corporation for further assistance or instructions on how to handle the affected strips.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0360-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-0360-2019 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.
