CoaguChek XS Patient Self Testing Care Kit 4837738001Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00365702125100), received between Aug 2, 2018 and Jul 27, 2026 — classified as 7 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (62 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 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026High Test Results

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50001112 ↗
• MalfunctionJul 17, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857881 ↗
• MalfunctionJun 22, 2026Low Test Results

  IT WAS ALLEGED THAT A PATIENT RECEIVED DISCREPANT RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(6). AT 9:05 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 3.0 INR. AT 9:08 A.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A VALUE OF 2.0 INR. THE PATIENT'S THERAPEUTIC RANGE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25581168 ↗
• MalfunctionJun 9, 2026Circuit Failure; Use of Device Problem

  WE RECEIVED AN ALLEGATION OF A COAGUCHEK XS METER SOFTWARE MALFUNCTION FOR ONE PATIENT. THE CUSTOMER INITIALLY CALLED DUE TO ERROR 3. DURING THE CALL, THE CUSTOMER ALLEGED THAT THE METER GAVE RESULTS USING EXPIRED TEST STRIPS. THE CUSTOMER REPORTED THE FOLLOWING METER RESULTS: ON (B)(6) 2026, THE METER RESULT WAS 2.6 INR. ON (B)(6) 2026, THE METER RESULT WAS 3.3 INR. ON (B)(6) 2026, THE METER RESULT WAS 3.9 INR. THE THERAPEUTIC RANGE IS 2-3 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448812 ↗
• MalfunctionJun 1, 2026Display Difficult to Read

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE WITH THE COAGUCHEK XS METER AFFECTING THE INTERPRETATION OF RESULTS. THE CUSTOMER ALLEGED THAT WHILE ATTEMPTING TO TEST, AN ERROR MESSAGE WAS DISPLAYED ON THE SCREEN, WHICH FLUCTUATED BETWEEN SHOWING " ERROR + 5" AND "ERROR + 9". WITH THE ASSISTANCE OF TECHNICAL SUPPORT, THE CUSTOMER PERFORMED A TEST, AND THE RESULT APPEARED TO BE 1.9 INR, BUT THEN THE RESULT CHANGED FROM 1.9 INR TO 1.4 INR. THE THERAPEUTIC RANGE WAS 2.0 INR - 4.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347329 ↗
• MalfunctionMay 11, 2026Image Display Error/Artifact; Lack of Maintenance Documentation or Guidelines

  THERE WAS AN ALLEGATION THAT THE COAGUCHEK XS PST CARE KIT GAVE A RESULT OF 24 INSTEAD OF 2.4 INR. IT IS UNCLEAR IF THERE IS AN ISSUE WITH THE DISPLAY OR IF THE METER IS SET IN THE INCORRECT UNIT OF MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135313 ↗
• MalfunctionApr 16, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE INR RESULTS FOR ONE PATIENT TESTED WITH THE COAGUCHEK XS PST CARE KIT METER. THE METER RESULT AT 9:44 AM WAS 7.7 INR. THE METER RESULT AT 9:48 AM WAS 5.7 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 INR - 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895575 ↗
• MalfunctionApr 14, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK XS METER. AT 3:13 P.M., THE METER RESULT WAS 2.4 INR. AT 3:16 P.M., THE METER RESULT WAS 1.9 INR. AT 4:57 P.M., THE METER RESULT WAS 3.4 INR. AT 5:42 P.M., THE METER RESULT WAS 1.1 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. THE PATIENT STOPPED TAKING THEIR WARFARIN MEDICATION FOR 2 DAYS BASED ON THE RESULT OF 1.1 INR AND CONFIRMED NO HARM OR SERIOUS INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877030 ↗
• MalfunctionApr 2, 2026Device Difficult to Setup or Prepare; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM A COAGUCHEK XS METER. IT WAS REPORTED THAT THE METER DISPLAYED A RECURRING "SET + DATE FLASH" ERROR, AND THE PATIENT WAS UNABLE TO INITIATE A MEASUREMENT. THE ISSUE WAS NOT RESOLVED BY REBOOTING THE METER. IT WAS ALSO NOTED THAT THE METER'S TIME AND DATE WERE INCORRECTLY SET. THE METER RESULT WAS 1.5 INR AT 09:44 AM. THE METER RESULT WAS 2.4 INR AT 11:01 AM. THE METER RESULT WAS 1.4 INR AT 02:12 PM. IT COULD NOT BE CONFIRMED IF THE RESULT TIMES WERE ACCURATE OR IF THEY WERE PERFORMED WITHIN 4 HOURS. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 INR - 3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765458 ↗
• MalfunctionJan 12, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A QUESTIONABLE HIGH INR RESULT FOR ONE PATIENT TESTED WITH THE COAGUCHEK XS PST METER, WHEN COMPARED WITH ANOTHER COAGUCHEK METER. THE METER RESULT AT THE DOCTOR'S OFFICE WAS 2.5 INR, WHILE THE PATIENT'S METER RESULT WAS 5.0 INR. THE TIME DIFFERENCE BETWEEN THE MEASUREMENTS WAS WITHIN MINUTES. THE PATIENT¿S THERAPEUTIC RANGE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036054 ↗
• MalfunctionJan 8, 2026Adverse Event Without Identified Device or Use Problem

  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 ONE PATIENT. THE INITIAL RESULT AT 6:41 PM WAS 4.3 INR, AND ANOTHER RESULT AT 6:55 PM WAS 5.6 INR. THE PATIENT WAS NOT SURE IF HER HANDS WERE COMPLETELY DRY WHEN DOING THE FIRST TEST.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24009889 ↗
• MalfunctionAug 14, 2025Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS AN ALLEGATION OF A DISPLAY ISSUE ON A COAGUCHEK XS METER. THE CUSTOMER STATED THAT THE METER DISPLAY IS FADED AND MISSING SEGMENTS. THEY ALSO ALLEGED THAT THEY RECEIVED A RESULT OF 1.2 INR, BUT THEY WERE NOT SURE AS THE RESULTS WERE FADED. THE CUSTOMER PERFORMED A DISPLAY CHECK AND CONFIRMED THAT THERE WERE MISSING SEGMENTS IN THE NUMBER 8 ON THE DISPLAY SCREEN. THE CUSTOMER ALSO CHANGED THE BATTERIES ON THE METER AND THE SCREEN WAS STILL FADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805872 ↗
• MalfunctionJul 16, 2025Image Display Error/Artifact; Image Display Error/Artifact

  THERE WAS A METER DISPLAY ISSUE WITH COAGUCHEK XS METER, SERIAL NUMBER (B)(6). CUSTOMER ALLEGED THE METER HAD A DISPLAY MALFUNCTION THAT RESULTED IN A MISINTERPRETATION OF RESULTS. THE RESULTS FIELD OF THE METER IS FADED. THE RESULTS FIELD DISPLAYED A RESULT OF 5.4 INR ON THE DAY OF THE EVENT. CUSTOMER DID NOT BELIEVE THIS WAS THE CORRECT RESULT DUE TO THE DISPLAY ISSUE. THE CUSTOMER DID NOT REPORT THE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521917 ↗
• MalfunctionFeb 13, 2025Circuit Failure; Failure to Power Up; Battery Problem; Device Contamination with Chemical or Other Material; Circuit Failure; Failure to Power Up; Battery Problem; Device Contamination with Chemical or Other Material

  THERE WAS AN ALLEGATION OF BURNING ON COAGUCHEK XS METER, SERIAL NUMBER (B)(6). CUSTOMER STATED THE METER WOULD NOT POWER ON AND ONE OF THE BATTERIES HAD CORRODED AND LEAKED IN THE BATTERY COMPARTMENT. THEY ATTEMPTED TO CHANGE THE BATTERIES AND NOTICED THERE WAS A BLACK/BURNT SPOT ON THE BATTERY DOOR AS WELL AS A MELTED SPOT ON THE BOTTOM OF THE BATTERY DOOR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375125 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Non Reproducible Results; Adverse Event Without Identified Device or Use Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A PATIENT EXPERIENCING A FALL, WHICH RESULTED IN AN INFECTED HEMATOMA, AFTER ALLEGEDLY BEING UNABLE TO USE THE COAGUCHEK XS METER DUE TO ERROR MESSAGES. ON (B)(6) 2024 THE METER RESULT WAS REPORTEDLY 2.6 INR. ALLEGEDLY, THE PATIENT HAD BEEN UNABLE TO USE THE METER SINCE (B)(6) 2024 DUE TO RUNNING OUT OF TEST STRIPS AFTER REPEATEDLY RECEIVING ERROR MESSAGE 5 ON THE METER. PRODUCT LABELING INDICATES THAT ERROR 5 IS A BLOOD APPLICATION ERROR. PRODUCT LABELING STATES: "ERROR APPLYING BLOOD TO THE TEST STRIP OF BLOOD SAMPLE SIZE WAS TOO SMALL." THE PATIENT REPORTEDLY TOLD HER PHYSICIAN'S OFFICE SHE WAS OUT OF TEST STRIPS; SHE WAS ALLEGEDLY NOT ADVISED TO DO ANYTHING OR COME IN FOR TESTING. THE PATIENT DID NOT HAVE AN ALTERNATIVE METHOD OF TESTING AVAILABLE. THE PATIENT WAS REPORTEDLY IN THE PROCESS OF TRYING TO OBTAIN ADDITIONAL TESTING STRIPS WHEN SHE FELL ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT REPORTEDLY VISITED HER GENERAL PRACTITIONER DUE TO HAVING A HEMATOMA. THE HEMATOMA WAS INFECTED AND THE PATIENT WAS ALLEGEDLY ADVISED TO GO TO THE EMERGENCY ROOM. THE PATIENT'S RESULT IN THE EMERGENCY ROOM FROM AN UNKNOWN LABORATORY METHOD WAS ALLEGEDLY 7.0 INR. W

  Patient problems: Hematoma

  MAUDE report 20843130 ↗
• InjuryNov 8, 2024No Device Output; High Test Results; Adverse Event Without Identified Device or Use Problem; No Device Output; High Test Results; Adverse Event Without Identified Device or Use Problem

  WE RECEIVED AN ALLEGATION OF UNSPECIFIED ERROR MESSAGES ON A COAGUCHEK ® XS SYSTEM THAT MAY HAVE CONTRIBUTED TO A PATIENT'S INTRACRANIAL HEMORRHAGE AND NEED FOR HOSPITALIZATION. THE REPORTER COULD NOT REMEMBER THE SPECIFIC ERROR MESSAGES THAT OCCURRED. THE PATIENT HAD REPORTEDLY BEEN UNABLE TO OBTAIN A RESULT ON THE METER BEFORE THE HOSPITALIZATION ON (B)(6) 2024 DUE TO UNSPECIFIED ERROR MESSAGES AFTER DOSING THE TEST STRIP. IT IS NOT KNOWN WHEN THE PATIENT LAST ATTEMPTED TO TEST ON THE DEVICE BEFORE THE EVENT. ERROR MESSAGES ARE DESIGNED FAIL SAFES TO PREVENT THE DEVICE FROM PRODUCING A RESULT WHEN CERTAIN OPERATING CONDITIONS ARE MET. CLARIFICATION ON THE SPECIFIC ERROR MESSAGES RECEIVED HAS BEEN REQUESTED BUT NOT PROVIDED. THE FOLLOWING RESULTS FROM (B)(6) 2024 WERE PROVIDED FROM THE MEMORY OF THE METER: ON (B)(6) 2024 THE RESULT WAS REPORTEDLY 6.1 INR. ON (B)(6) 2024 THE RESULT WAS REPORTEDLY 4.9 INR. ON (B)(6) 2024 THE RESULT WAS REPORTEDLY 1.2 INR. THE PATIENT¿S THERAPEUTIC RANGE IS REPORTEDLY 2.0 ¿ 3.0 INR WITH AN ALLEGED TESTING FREQUENCY OF ONCE PER WEEK. ON (B)(6) 2024 THE PATIENT ACCIDENTALLY BUMPED HIS HAND ON THE WALL. REPORTEDLY, THE BLEEDING ON THE PATIENT¿S HAND COU

  Patient problems: Coagulation Disorder; Intracranial Hemorrhage

  MAUDE report 20642536 ↗
• MalfunctionJan 8, 2024Device Difficult to Setup or Prepare; Non Reproducible Results; Device Difficult to Setup or Prepare; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF AN ISSUE WITH A COAGUCHEK XS METER. THE PATIENT ALLEGED RUNNING A TEST ON THE METER AND RECEIVING AN ERROR 5 MESSAGE AND THEN A RESULT OF 1.6 INR WITH THE SAME TEST STRIP. AN ERROR 5 IS RELATED TO AN ISSUE APPLYING BLOOD TO THE TEST STRIP. THE PATIENT REPORTED THE RESULT OF 1.6 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464259 ↗
• MalfunctionDec 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COAGUCHEK XS METER. THE INITIAL RESULT WAS ALLEGEDLY 23.8 AND THE PATIENT WENT TO THE ER FOR TESTING. THE LABORATORY RESULT USING AN UNKNOWN REAGENT WAS 1.6 INR. IT WAS DETERMINED THE METER WAS SET TO DISPLAY RESULTS IN SECONDS AND NOT INR. THE RESULT FROM THE METER MEMORY AT 10:29 WAS 1.9 INR (22.8 SEC). THE RESULT FROM THE METER MEMORY AT 10:32 WAS 2.1 INR (23.8 SEC). THE RESULT FROM THE METER MEMORY AT 10:39 WAS 1.9 INR (22.4 SEC). A DIFFERENT FINGER WAS USED FOR EACH TEST. THE THERAPEUTIC RANGE WAS 2.0-3.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374545 ↗
• MalfunctionDec 20, 2023Image Display Error/Artifact; Misassembly by Users; Image Display Error/Artifact; Misassembly by Users

  WE RECEIVED AN ALLEGATION ABOUT A FADED DISPLAY WHEN A PATIENT TESTED WITH A COAGUCHEK XS METER. THE REPORTER ALLEGED THAT SINCE THE METER WAS FLICKERING, HE REPLACED THE BATTERIES. HE ALSO ALLEGED THAT THE METER DID NOT POWER ON AFTER THAT. THE REPORTER WAS ADVISED TO TURN OFF THE METER AND PRESS THE M BUTTON TO ACCESS THE METER MEMORY. THE METER WAS POWERED ON WITH AN ERROR MESSAGE. THE REPORTER ALLEGED THAT HE COULD NOT DETERMINE IF THE ERROR MESSAGE WAS AN ERROR 4 OR AN ERROR 9 AS THE NUMBERS WERE FADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365979 ↗
• MalfunctionDec 19, 2023Calibration Problem; Non Reproducible Results; Calibration Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM COAGUCHEK XS METER, SERIAL NUMBER (SN) (B)(6), COMPARED TO ANOTHER COAGUCHEK XS METER, SERIAL NUMBER (B)(6). AT 3:00 P.M., THE RESULT FROM METER SN (B)(6) WAS 3.5 INR. AT 3:05 P.M., THE RESULT FROM METER SN (B)(6) WAS 2.5 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 3.0 - 4.0 INR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356695 ↗
• MalfunctionNov 30, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A METER DISPLAY ISSUE ON COAGUCHEK XS METER, SERIAL NUMBER UNKNOWN. THE PATIENT'S DAUGHTER ALLEGED THAT THE SCREEN APPEARS FOGGY AND CANNOT READ THE RESULTS. SHE ALLEGED THEY REPLACED THE BATTERIES BUT THE ISSUES PERSISTED AND THAT THERE ARE MISSING SEGMENTS IN THE RESULTS FIELD. SHE STATED THAT SHE PERFORMED A TEST ON 05-NOV-2023 AND IT APPEARED TO GIVE A RESULT OF 2.1 INR BUT WAS UNSURE AS THERE WERE SEGMENTS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239197 ↗
• MalfunctionNov 16, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  WE RECEIVED AN ALLEGATION OF "VASTLY DIFFERENT" RESULTS ON A COAGUCHEK XS METER. IT WAS DETERMINED THE PATIENT HAD CHANGED THE BATTERIES IN THE METER ON (B)(6) 2023 AND THE UNITS WERE NOT RESET TO INR; THE RESULTS WERE IN SECONDS (SEC) UNIT OF MEASURE. THE CALL AGENT ASSISTED WITH RESETTING THE METER TO READ IN INR UNIT OF MEASURE. DISCREPANT RESULTS IN INR FROM (B)(6) 2023 WERE IDENTIFIED. THE RESULT AT 12:52 P.M. USING STRIP LOT 68883822 (EXPIRATION 30-SEP-2024) WAS 4.7 INR. THE RESULT AT 3:54 P.M. WITH A DIFFERENT FINGER USING STRIP LOT 66283721 (EXPIRATION 30-JUN-2024) WAS 2.8 INR. THE PATIENT¿S THERAPEUTIC RANGE IS 2 -3 INR WITH A TESTING FREQUENCY OF EVERY 2 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148454 ↗
• MalfunctionNov 7, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH THE DISPLAY OF COAGUCHEK XS METER SERIAL NUMBER (B)(6). THE REPORTER INITIALLY STATED THAT THE "O" WAS MISSING FROM THE DISPLAY FOR THE WORD "ON" WHEN GOING INTO THE BEEPER SETTING. THE REPORTER STATED THAT A VALUE OF .6 INR WAS MEASURED ON THE METER ON (B)(6) 2023 AND THE FIRST SEGMENT OF THE RESULTS FIELD WAS MISSING. WHEN CHECKING THE CODE NUMBER OF THE TEST STRIPS ON THE DISPLAY, THE MIDDLE DIGIT WAS MISSING. WHEN PERFORMING A CHECK OF THE FULL DISPLAY, THE MIDDLE "8" WAS MISSING FROM THE RESULTS FIELD. THE REPORTER CHECKED THE BATTERY COMPARTMENT AND NO CORROSION WAS OBSERVED. THE REPORTER DID NOT ALLEGE ANY RESULT MISINTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18087399 ↗
• MalfunctionNov 7, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION ABOUT A FADED DISPLAY WHEN USING COAGUCHEK XS PST METER. THE REPORTER CHECKED THE DISPLAY AND MENTIONED THAT IT LOOKED NORMAL WHEN LOOKING STRAIGHT AT THE SCREEN, ALLEGING THAT THE SCREEN LOOKED FADED WHEN THE METER WAS HELD AT AN ANGLE. THE REPORTER ALSO ALLEGED THAT WHEN CHECKING THE METER'S MEMORY, SEGMENTS WERE MISSING FROM THE RESULTS FIELD. SHE REPLACED THE BATTERIES AND STATED THAT THERE WERE NO SIGNS OF MOISTURE OR DEBRIS INSIDE THE BATTERY COMPARTMENT. THE REPORTER THOUGHT THAT THERE MIGHT BE SOME RESIDUE ON THE HEATER PLATE, BUT SHE WAS NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085623 ↗
• MalfunctionOct 26, 2023Image Display Error/Artifact; Image Display Error/Artifact

  WE RECEIVED AN ALLEGATION ABOUT A DISPLAY ISSUE WHEN USING COAGUCHEK XS PST METER. THE REPORTER ALLEGED MISSING SEGMENTS ON THE DISPLAY FIELD WHEN INSERTING THE STRIP WHERE THE CODE NUMBER WAS FLASHING ON THE SCREEN AND PARTS OF THE NUMBERS WERE MISSING. THE REPORTER ADVISED THAT SHE COULD ONLY ACCESS THE METER MEMORY AND SEE THE LAST RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015175 ↗

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