CoaguChek XS PT strips 4625315160Recalls & reported problems

Summary

The FDA's MAUDE database contains 604 adverse event reports that list this exact device (DI 00365702128101), received between Jul 11, 2018 and Sep 16, 2026 — classified as 5 injuries, 599 malfunctions.

The most frequently reported specific device problem is “High Test Results” (485 reports).

3 other recalls cover devices cleared under the same FDA submission (K060978); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 604 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788039 ↗
• MalfunctionMay 20, 2026Device Difficult to Setup or Prepare; Non Reproducible Results

  THERE WAS AN ALLEGATION OF DISCREPANT INR RESULTS FOR 1 PATIENT TESTED ON A COAGUCHEK XS SYSTEM. THE RESULTS WERE 3.2 INR AND 4.4 INR. THE TIMEFRAME BETWEEN TESTS WAS NOT PROVIDED. THE PATIENT'S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232975 ↗
• MalfunctionApr 21, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE INR RESULT FROM THE COAGUCHEK XS PLUS METER. THE FIRST METER RESULT WAS 5.0 INR. THE SECOND METER RESULT WITHIN 4 HOURS WAS 3.5 INR. THE PATIENT¿S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945243 ↗
• MalfunctionFeb 9, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS PROFESSIONAL METER COMPARED TO A PATIENT'S ROCHE METER (TYPE OF METER UNSPECIFIED). THE PATIENT'S METER (METER A) RESULT WAS 3.2 INR. DUE TO THE HIGH RESULT, THE PATIENT WAS TESTED AT THE HOSPITAL. THE LABORATORY RESULT WAS 3.2 INR. THE RESULT ON THE HOSPITAL'S COAGUCHEK XS PROFESSIONAL METER (METER B) WAS 5.4 INR. THIS RESULT WAS QUESTIONED. THE TIME LAPSE BETWEEN TESTS IS UNKNOWN. DUE TO THE LABORATORY RESULT MATCHING THE RESULT FROM METER A, THE RESULT FROM METER A WAS NOT QUESTIONED. THE PATIENT¿S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296996 ↗
• MalfunctionJan 12, 2026Adverse Event Without Identified Device or Use Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK VANTUS METER. ON (B)(6) 2025 AT 7:30 AM, THE RESULT WAS 3.2 INR. AT 7:35 AM, THE RESULT WAS 2.1 INR. ON (B)(6) 2025 AT 7:05 AM, THE RESULT WAS 1.5 INR. AT 7:10 AM, THE RESULT WAS 1.9 INR. AT 7:15 AM, THE RESULT WAS 2.2 INR. ON (B)(6) 2025 AT 7:15, THE RESULT WAS 2.6 INR. AT 7:20, THE RESULT WAS 2.5 INR. AT 8:20, THE RESULT WAS 2.0 INR. THE THERAPEUTIC RANGE WAS 1.8 TO 2.0 INR. THE PATIENT "DOES A ROUTINE WEEKEND VEGETABLE MEAL TO MAINTAIN NORMAL VITAMIN K LEVELS".

  Patient problems: Easy Bruising; Hematuria

  MAUDE report 24037653 ↗
• MalfunctionDec 19, 2025Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT A PATIENT RECEIVED DISCREPANT RESULTS WHEN TESTING WITH THEIR DOCTOR'S COAGUCHEK XS METER (SERIAL NUMBER UNKNOWN). A SAMPLE FROM THE PATIENT WAS TESTED USING THE DOCTOR'S METER, RESULTING IN A VALUE OF 2.9 INR. WITHIN 30 MINUTES OF THE INITIAL TEST, A SAMPLE FROM THE PATIENT WAS TESTED USING THE DOCTOR'S METER, RESULTING IN A VALUE OF 4.0 INR. A VENOUS SAMPLE COLLECTED FROM THE PATIENT AT AN UNKNOWN TIME ON (B)(6) 2025, RESULTED IN A LABORATORY VALUE OF 3.2 INR. THE PATIENT'S THERAPEUTIC RANGE WAS 3.0 - 3.5 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854241 ↗
• MalfunctionDec 17, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK XS METER. AT 01:29 PM, THE RESULT WAS 4.7 INR. AT 01:31 PM, THE RESULT WAS 3.6 INR. THE THERAPEUTIC RANGE WAS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826658 ↗
• MalfunctionDec 9, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK XS PLUS METER. AT 10:56 AM THE METER RESULT WAS 7.3 INR. AT 11:08 AM THE METER RESULT FROM ANOTHER COAGUCHEK XS METER WAS 3.5 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756582 ↗
• MalfunctionAug 5, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE INR RESULTS FROM THE COAGUCHEK XS METER. THE METER RESULT WAS 4.4 INR. THE METER RESULT WAS 3.1 INR. THE TESTS WERE PERFORMED WITHIN 4 HOURS OF EACH OTHER. THE PATIENT'S THERAPEUTIC RANGE IS 2.8-3.8 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720644 ↗
• MalfunctionApr 1, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER, SERIAL NUMBER (B)(6) COMPARED TO A PATIENT'S COAGUCHEK XS METER WITH (B)(6) SERIAL NUMBER. AT 12:30 PM THE METER RESULT FROM THE PATIENT'S COAGUCHEK XS METER (B)(6) WAS 4.6 INR. THE PATIENT WAS USING TEST STRIP LOT 76900023 WITH EXPIRATION DATE 31-OCT-2025. AT 12:30 PM THE METER RESULT WAS 2.4 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0 INR. CUSTOMER TESTS ON A WEEKLY BASIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739200 ↗
• MalfunctionMar 6, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS PLUS METER, SERIAL NUMBER UNKNOWN COMPARED TO A PATIENT'S COAGUCHEK VANTUS METER SERIAL NUMBER (B)(6). AT 12:30 PM THE COAGUCHEK XS PROFESSIONAL METER RESULT WAS 2.6 INR. AT 4:04 PM THE COAGUCHEK VANTUS METER RESULT WAS 1.6 INR. THE PATIENT WAS USING STRIP LOT 77503323 WITH EXPIRATION 31-OCT-2025. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0 INR. CUSTOMER TESTS ON A WEEKLY BASIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535255 ↗
• MalfunctionNov 12, 2024Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT A PATIENT RECEIVED DISCREPANT RESULTS WHEN TESTING WITH HIS COAGUCHEK XS METER SERIAL NUMBER (B)(6) AND A SECOND COAGUCHEK XS METER (UNKNOWN SERIAL NUMBER) USED AT THE DOCTOR'S OFFICE. THIS MEDWATCH WILL APPLY TO THE TEST STRIPS USED ON THE DOCTOR'S OFFICE METER. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TEST STRIPS USED ON THE PATIENT'S METER. AT 10:30 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE PATIENT'S METER, RESULTING IN A VALUE OF 4.4 INR. AT 11:30 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE DOCTOR'S OFFICE METER, RESULTING IN A VALUE OF 3.1 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.6 - 3.6 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669512 ↗
• MalfunctionOct 18, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK XS PRO METER. THE RESULT FROM THE PROFESSIONAL METER WAS 2.7 INR. THE RESULT FROM THE PATIENT'S METER WAS 1.8 INR THE THERAPEUTIC RANGE WAS 2.0-3.0 INR AND THE TESTING FREQUENCY VARIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20485464 ↗
• MalfunctionSep 10, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR 1 PATIENT TESTED WITH A COAGUCHEK XS PRO METER (FACILITY'S METER) WHEN COMPARED TO A DIFFERENT COAGUCHEK XS METER (PATIENT'S METER). ON (B)(6) 2024 AT 6:35 PM THE PATIENT WAS TESTED WITH THE FACILITY'S METER AND HAD A METER RESULT OF 2.4 INR WHILE AT 6:48 PM THE PATIENT WAS TESTED WITH HIS METER AND HAD A METER RESULT OF 3.4 INR. THE PATIENT WAS TESTED USING 2 DIFFERENT INDEX FINGERS. THE PATIENT¿S THERAPEUTIC RANGE WAS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183979 ↗
• MalfunctionSep 10, 2024Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  WE RECEIVED AN ALLEGATION OF AN INCONSISTENT EXPIRATION DATE FOR COAGUCHEK XS SYSTEM TEST STRIPS. THE REPORTER CALLED TO CONFIRM THE EXPIRATION DATE FOR THE REPORTED TEST STRIP LOT. THE REPORTER STATED THAT SHE HAS AN EXPIRATION DATE OF (B)(6) 2024 WHILE THE NURSE AT AN OFF-SITE CLINIC REPORTED THE EXPIRATION DATE ON THE LABEL AS (B)(6) 2024. (B)(6) 2024 IS THE CORRECT EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182647 ↗
• MalfunctionAug 23, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR (1) PATIENT WITH COAGUCHEK XS METER CPL. CUSTOMER'S THERAPEUTIC RANGE IS 2.5-3.5 INR. THIS REPORT IS RELATED TO MFG REPORT NO 1823260-2024-02448 (REPORTED ON COAGUCHEK VANTUS). THIS MEDWATCH IS REPORTING ON THE COAGUCHEK XS METER CPL USED AT DOCTOR'S OFFICE. PATIENT REPORTED THE FOLLOWING: ON (B)(6) 2024 AT 8:35 AM THE PATIENT RECEIVED A RESULT OF 4.8 INR ON THE VANTUS METER. ON (B)(6) 2024 AT 10:42 AM THE PATIENT RECEIVED A RESULT OF 3.5 INR ON THE VANTUS METER. 1-2 HOURS LATER, THE PATIENT HAD A TEST CONDUCTED AT THE DOCTOR'S OFFICE USING A COAGUXS METER AND RECEIVED A RESULT OF 3.6 INR. HEALTHCARE PROVIDER AT DOCTOR'S OFFICE REPORTED: PATIENT WAS TESTED ON THE OFFICE METER ON (B)(6) 2024 AT 2:11 PM RECEIVING A RESULT OF 3.9 INR. PATIENT TESTED USING HOME METER AND RECEIVED A RESULT OF 4.3 INR. METER TO LAB COMPARISON WAS GREATER THEN 4 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047339 ↗
• MalfunctionAug 13, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR (1) PATIENT WITH A COAGUCHEK XS PLUS METER AT THEIR DOCTOR'S OFFICE. THIS MDR IS TO REPORT THE RESULTS OBTAINED ON THE PATIENT'S COAGUCHEK XS METER. REFER TO THE MDR WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE REPORT ON THE PATIENT'S COAGUCHEK XS. ON (B)(6) 2024 AT 7:06AM, THE PATIENT RECEIVED RESULTS 4.7 INR. ON (B)(6) 2024 AT 7:12AM, THE PATIENT RECEIVED A RESULT OF 3.7 INR. ON (B)(6) 2024 AT 9:45AM, THE PATIENT RECEIVED A RESULT OF 5.0 INR. ON (B)(6) 2024 AT 10:00AM RESULT AT DOCTOR'S OFFICE USING COAGUCHEK XS PLUS METER OF 5.3 INR. THE PATIENT¿S THERAPEUTIC RANGE WAS PROVIDED 3.0 TO 4.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973902 ↗
• MalfunctionAug 8, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS ON A COAGUCHEK XS PLUS WHEN COMPARED TO THE PATIENT'S COAGUCHEK XS METER. ON (B)(6) 2024 AT 1:22PM, THE PATIENT RECEIVED THE FOLLOWING INR RESULTS: PATIENT'S COAGUCHEK XS METER RESULT 1.2 ON (B)(6) 2024 AT 1:30PM, THE PATIENT RECEIVED THE FOLLOWING INR RESULTS: CLINIC'S COAGUCHEK XS METER RESULT 6.6 THE PATIENT¿S THERAPEUTIC RANGE WAS PROVIDED 2.5 - 3.0 INR. INTERVAL OF TESTING IS 1 X WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938204 ↗
• MalfunctionJul 23, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR (1) PATIENT TESTED WITH TWO COAGUCHEK XS PLUS METERS. THE PATIENT¿S THERAPEUTIC RANGE WAS 2.0-3.0INR. AT 4:23 AM, THE RESULT FROM THE PATIENT WAS 4.2INR WHEN TESTED WITH THE FIRST METER. AT 4:31 AM, THE RESULT FROM THE PATIENT WAS 1.9INR, WHEN TESTED WITH THE SECOND METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808916 ↗
• MalfunctionJul 23, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED WITH THE PATIENT'S COAGUCHEK XS METER IN COMPARISON TO A DOCTOR'S OFFICE COAGUCHEK XS METER. THIS MEDWATCH WILL APPLY TO THE DOCTOR'S OFFICE COAGUCHEK XS METER. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED THE PATIENT'S COAGUCHEK XS METER. ON (B)(6)2024 A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER RESULTING IN A RESULT OF 1.8 INR. WITHIN FOUR HOURS A SAMPLE FROM THE PATIENT WAS TESTED AT THE DOCTOR'S OFFICE USING A COAGUCHEK XS METER RESULTING IN A VALUE OF 2.8 INR. THE PATIENT¿S THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE PATIENT¿S TESTING FREQUENCY IS WEEKLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804617 ↗
• MalfunctionJun 28, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER, SERIAL NUMBER UNKNOWN, COMPARED TO A PATIENT COAGUCHEK XS METER, SERIAL NUMBER (B)(6) . AT 7:00 AM, THE PATIENT METER, (B)(6) , RESULT WAS 1.9 INR. AT 8:30 AM, THE PROFESSIONAL METER RESULT WAS 2.6 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.5-3.5 INR. PATIENT TESTS WEEKLY OR EVERY TWO WEEKS. THE PATIENT HAD A DIET CHANGE OF AVOIDING GREENS SINCE JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632232 ↗
• MalfunctionMay 10, 2024Inaccurate Information; Inaccurate Information

  THERE WAS AN ALLEGATION OF AN INCORRECTLY PRINTED EXPIRATION DATE ON A COAGUCHEK ® XS SYSTEM TEST STRIP VIAL. IT WAS ALLEGED THAT AN ERROR 3 OCCURRED. IT WAS ALLEGED THAT THE LABEL ON THE TEST STRIP VIAL HAD AN EXPIRATION DATE OF 2024-07-31. THE STRIP LOT DATABASE INDICATES THE ALLEGED TEST STRIP LOT HAS AN EXPIRATION DATE OF 2024-01-31.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285120 ↗
• MalfunctionApr 16, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS PLUS METER COMPARED TO A LABORATORY RESULT USING ANOTHER COAGUCHEK XS PLUS METER. THE RESULT FROM METER A WAS 3.2 INR. THE RESULT FROM METER B WAS 2.4 INR. THE RESULTS WERE OBTAINED LESS THAN 4 HOURS APART. THE PATIENT¿S THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE PATIENT¿S TESTING FREQUENCY IS EVERY 5-6 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117552 ↗
• MalfunctionApr 1, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM A COAGUCHEK PRO METER. AT 6:51 AM, THE INITIAL RESULT FROM THE PATIENT METER (SERIAL NUMBER (B)(6) WAS 1.3 INR. AT 9:07 AM, THE PATIENT WENT TO THE DOCTOR'S OFFICE AND THE RESULT FROM THE PROFESSIONAL METER WAS 3.3 INR. THE RETEST RESULT USING THE PATIENT'S METER AND THE TEST STRIPS FROM THE DOCTOR'S OFFICE WAS 3.1 INR. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR AND THE PATIENT TESTS WEEKLY. THE PATIENT HAD A DIETARY CHANGE OF EATING ORANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011061 ↗
• MalfunctionFeb 12, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULT WITH COAGUCHEK XS METER SERIAL NUMBER: (B)(6) COMPARED TO A SECOND COAGUCHEK XS METER SERIAL NUMBER: (B)(6). AT 9:52 AM, THE RESULT FROM METER SERIAL NUMBER: (B)(6) WAS 5.4 INR USING TEST STRIP LOT 68883611 WITH EXPIRATION DATE 30-SEP-2024. AT 10:03 AM, THE RESULT FROM METER SERIAL NUMBER: (B)(6) WAS 4.0 INR USING TEST STRIP LOT 70302411. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687985 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060978. One submission often covers many models, so check the product and lot details in each record.

• Z-0803-2021 · Dec 2, 2020 · Terminated
  CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975
• Z-1584-2013 · May 16, 2013 · Terminated
  CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin
• Z-2002-2009 · Jul 22, 2009 · Terminated
  Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus Sy