Lower riskMedical device recall · FDA · Published December 2, 2020
Roche CoaguChek XS PST Meters: Possible Misreading of Blood Clotting Results
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 CoaguChek XS PST Meters: Possible Misreading of Blood Clotting Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63741-roche-coaguchek-xs-pst-meters-possible-misreading-of-blood-clotting. Based on FDA recall #Z-0804-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled CoaguChek XS PST Meters on Dec. 2, 2020, according to the FDA. The devices may display incorrect blood-clotting time units, posing a misinterpretation hazard. Owners should follow instructions to ensure the meter displays INR results.
The meters may display measuring units incorrectly, switching from INR to %Quick or Seconds. This possible misinterpretation of displayed measuring units is the primary hazard reported in the recall record.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls since July 2, 2019. Recent similar product recalls include Boston Scientific LUX-Dx II Plus Model M312 (March 30, 2026), HemosIL SynthAFax Partial Thromboplastin Time Tests (Nov. 18, 2025), and Abbott i-STAT EG6+ Cartridges (April 1, 2026).
How to tell if you have this one
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.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide
Recall number
Product, codes & lots
Quantity
Z-0803-2021
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001; All serial numbers
212,093 units
Z-0804-2021
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001; All serial numbers
716,880 units
Based on the official FDA remedy
What to do — step by step
Check Display Units
Ensure the meter shows INR results by following the provided instructions. If it displays %Quick or seconds, contact Roche for guidance.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0804-2021 (December 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0804-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.