COAGUCHEK XS PT TEST 6 STRIP 4625374160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,681 adverse event reports that list this exact device (DI 00365702127104), received between Jul 12, 2018 and Sep 29, 2026 — classified as 3 deaths, 109 injuries, 1,569 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1,098 reports).

4 other recalls cover devices cleared under the same FDA submission (K062925); 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 1,681 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937051 ↗
• MalfunctionSep 29, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932051 ↗
• MalfunctionSep 25, 2026No Device Output; Adverse Event Without Identified Device or Use Problem

  There was an allegation of questionable INR results for 1 patient using the COAGUCHEK XS PT TEST 6 STRIP on a COAGUCHEK XS PST CARE KIT. The patient provided the following results:1.2 INR, 1.0 INR ,1.1 INR ,1.3 INR ,1.6 INR, 2.4 INR .The patient stated that the results were obtained before her hospitalization on (b)(6)2026. The specific dates and times of the results were requested, but not provided.The patient tests on the meter every two days. The therapeutic range is 2.0 to 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898164 ↗
• MalfunctionSep 17, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806941 ↗
• MalfunctionSep 15, 2026Non Reproducible Results

  There was an allegation of questionable INR results on a COAGUCHEK XS PST meter.The patient tested 5 times within 30 minutes. The result at 10:40 a.m. was 4.5 INR. The result at 10:41 a.m. was 3.5 INR. The result at 10:43 a.m. was 3.0 INR. The result at 11:03 a.m. was 4.2 INR. The result at 11:10 a.m. was 4.2 INR. The same finger was used for some of the tests, but different fingers were used for the results of 3.0 INR at 10:43 a.m. and 4.2 INR at 11:10 a.m. The patient¿s therapeutic range is 2.0 ¿ 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777939 ↗
• MalfunctionAug 18, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298343 ↗
• MalfunctionAug 14, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260182 ↗
• MalfunctionAug 13, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233744 ↗
• MalfunctionAug 13, 2026High Test Results

  Patient problems: Hematoma

  MAUDE report 50233550 ↗
• MalfunctionAug 5, 2026High Test Results; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146347 ↗
• MalfunctionJul 13, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25794818 ↗
• MalfunctionJun 26, 2026Device Difficult to Setup or Prepare

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED WITH THE COAGUCHEK XS PST CARE KIT. AT 2:41 PM, THE METER RESULT WAS 2.0 INR. AT 2:46 PM, THE METER RESULT WAS 2.9 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 TO 3.1 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636542 ↗
• MalfunctionJun 15, 2026Device Difficult to Setup or Prepare; High Test Results; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED THAT A PATIENT RECEIVED DISCREPANT RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). SAMPLES FROM THE PATIENT WERE MEASURED ON THE METER AT UNKNOWN TIMES ON (B)(6) 2026, RESULTING IN VALUES OF 3.0 INR AND 6.2 INR. AT AN UNKNOWN TIME ON (B)(6) 2026, THE PATIENT HAD A RESULT OF 2.1 INR WHEN TESTING WITH AN UNKNOWN LABORATORY METHOD. THE PATIENT'S THERAPEUTIC RANGE IS 3.0 INR TO 3.5 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503394 ↗
• InjuryJun 4, 2026High Test Results; Adverse Event Without Identified Device or Use Problem

  IT WAS ALLEGED THAT A PATIENT HAD BLOOD CLOTS WHILE USING COAGUCHEK XS METER SERIAL NUMBER (B)(6). STARTING ON (B)(6) 2026 UNTIL (B)(6) 2026, IT WAS ALLEGED THAT THE PATIENT HAD 2 BLOOD CLOTS. THE PATIENT'S DOCTOR ALLEGEDLY TREATED THE PATIENT WITH AN ANTIBIOTIC, CIPROFLOXACIN. THE PATIENT'S THERAPEUTIC RANGE WAS REPORTED AS 2.5 - 3.5 INR. THIS MEDWATCH IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25394384 ↗
• MalfunctionMay 27, 2026High Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT HIGH INR RESULTS WITH A COAGUCHEK VANTUS USA METER. THE RESULTS ON THE METER WERE 5.5 INR, 4.5 INR, AND 3.4 INR. THE RESULTS WERE OBTAINED ON THE SAME DAY; HOWEVER, THE SPECIFIC TIMEFRAME BETWEEN TESTS WAS NOT PROVIDED. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304206 ↗
• MalfunctionMay 22, 2026No Device Output; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE INR RESULT USING THE COAGUCHEK XS PT TEST 6 STRIP WITH THE COAGUCHEK XS PST CARE KIT FOR 1 INDIVIDUAL. THE INITIAL RESULT WAS 1.6 INR. A SECOND RESULT IN LESS THAN A 4-HOUR WINDOW WAS 2.5 INR. THE CUSTOMER'S THERAPEUTIC INR RANGE IS 2.0 INR TO 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257319 ↗
• InjuryMay 22, 2026Contamination; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED AN ALLEGATION THAT THE COAGUCHEK XS PST CARE KIT MAY HAVE CONTRIBUTED TO A PATIENT'S LUNG EMBOLISM. THE PATIENT WAS HAVING DIFFICULTY APPLYING THE BLOOD TO THE TEST STRIPS, AND SHE REPORTEDLY RECEIVED "ERROR 5" AND "ERROR 000". ON (B)(6) 2026, THE PATIENT WAS ALLEGEDLY HOSPITALIZED FOR A CLOT IN THE LUNG, AND IT WAS DISCOVERED THAT SHE HAD A LUNG EMBOLISM AND WAS GIVEN MEDICATION FOR THIS. THE PATIENT ALLEGED THAT THE METER GIVES HER ERRORS AND THAT THEY UTILIZE MORE THAN ONE TEST STRIP EVERY TIME THEY TRY TO DO THE INR TEST, SINCE THEY COME ACROSS THE ERROR ON THE METER, USUALLY ERROR 5; THEY ARE NOT SURE OF THE OTHER SPECIFIC ERRORS. THERE WERE REPORTEDLY NO CHANGES IN WARFARIN, MEDICATION, OR DIETARY CHANGES BEFORE THE HOSPITALIZATION, AND SHE HAD NO ILLNESS OR SICKNESS BEFORE THE HOSPITALIZATION. BEFORE THE EVENT, THE PATIENT'S PREVIOUS RESULTS WERE REPORTEDLY MOSTLY WITHIN HER THERAPEUTIC RANGE. THE PATIENT'S THERAPEUTIC RANGE IS REPORTEDLY 2 INR - 3 INR. FURTHER CLARIFICATION REGARDING THE FOLLOWING HAS BEEN REQUESTED BUT NOT PROVIDED: IF THE PATIENT ATTEMPTED TO TEST ON THE COAGUCHEK METER BETWEEN (B)(6) 2026 THE PATIENT'S INR IN THE HOSPITAL. IF THE PATIENT WAS

  Patient problems: Pulmonary Embolism

  MAUDE report 25256310 ↗
• MalfunctionMay 1, 2026Low Test Results; Non Reproducible Results

  IT WAS REPORTED THAT A PATIENT RECEIVED QUESTIONABLE RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). PLEASE REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. CLARIFICATIONS HAVE BEEN REQUESTED FOR ALL INFORMATION WRITTEN IN RED.

  Patient problems: Insufficient Information

  MAUDE report 25056411 ↗
• MalfunctionApr 30, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM A COAGUCHEK XS METER. AT 9:59 AM, THE METER RESULT WAS 2.3 INR. AT 1:57 PM, THE METER RESULT WAS 3.2 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.4 INR-2.6INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047129 ↗
• MalfunctionApr 28, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK XS METER. THE INITIAL RESULT WAS 3.9 INR. THE REPEAT RESULT WAS 2.9 INR. THE TIMEFRAME BETWEEN THE RESULTS WAS NOT KNOWN. THE THERAPEUTIC RANGE WAS 2-3 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014937 ↗
• MalfunctionApr 23, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER, SERIAL NUMBER (B)(6). THE METER RESULT WAS 5.5 INR. WITHIN 5 MINUTES, THE METER RESULT WAS 7.7 INR. THE LABORATORY RESULT USING AN UNKNOWN METHOD WAS 2.8 INR. THE EXACT TIME OF THE LABORATORY TEST WAS NOT PROVIDED. THE PATIENT¿S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968871 ↗
• MalfunctionApr 23, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK VANTUS METER, SERIAL NUMBER: (B)(6). AT 8:54 AM THE METER RESULT WAS 3.6 INR. AT 9:10 AM THE METER RESULT WAS 6.0 INR. AT 10:03 AM THE METER RESULT WAS 1.3 INR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968859 ↗
• MalfunctionApr 20, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM A COAGUCHEK VANTUS METER. AT 3:58 PM, THE METER RESULT WAS 6.0 INR. AT 4:00 PM, THE METER RESULT WAS 4.2 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932053 ↗
• MalfunctionApr 17, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM A COAGUCHEK XS METER. AT 4:29 PM, THE METER RESULT WAS 7.1 INR. AT 4:32 PM, THE METER RESULT WAS 6.5 INR. AT 4:54 PM, THE METER RESULT WAS 4.1 INR. AT 5:52 PM, THE METER RESULT WAS 7.0 INR. AT 5:56 PM, THE METER RESULT WAS 6.0 INR. THE LABORATORY RESULT ON THE SAME DAY WAS 3.8 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.3-2.6 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909954 ↗
• MalfunctionApr 16, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM ONE PATIENT TESTED WITH THE COAGUCHEK XS METER. THE METER RESULT WAS 5.3 INR. THE REPEAT METER RESULT WITHIN FOUR HOURS WAS 3.4 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062925. One submission often covers many models, so check the product and lot details in each record.

• Z-0804-2021 · Dec 2, 2020 · Terminated
  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 048
• Z-1581-2013 · May 16, 2013 · Terminated
  CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking antic
• Z-2003-2009 · Jul 22, 2009 · Terminated
  Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point
• Z-1594-2009 · May 13, 2009 · Terminated
  Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche