CoaguChek XS PT stripsRecalls & reported problems across all models

We found 2 models of CoaguChek XS PT strips by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 632 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2018 and Sep 16, 2026 — classified as 6 injuries, 626 malfunctions.

The most frequently reported specific device problem is “High Test Results” (505 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CoaguChek XS PT strips problems

CoaguChek XS PT strips models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CoaguChek XS PT strips 4625315160

  TEST, TIME, PROTHROMBIN
  604 reports
• CoaguChek XS PT strips 7797826160

  TEST, TIME, PROTHROMBIN
  28 reports

Recent CoaguChek XS PT strips adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 23, 2025Component Missing; Component Missing

  WE RECEIVED AN ALLEGATION THAT THE COAGUCHEK XS PT TEST 1X24 STRIPS BOX AND BOTTLE EXPIRATION DATES, AND THE TEST STRIP BOX AND THE CODE ON THE TEST STRIP DO NOT MATCH. THE REPORTER STATED THAT THE BOX'S EXPIRATION DATE IS 31-JUL-2025, AND THE BOTTLE'S IS 30-APR-2025; THE TEST STRIP CODE ON THE BOX IS 138, AND THE CODE ON THE TEST STRIP IS 117. THE REPORTER DID NOT USE THE TEST STRIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307149 ↗
• 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 ↗

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