CardioChek® Plus Professional Analyzer 2700Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00381932700016), received between Mar 26, 2019 and Mar 20, 2026 — classified as 114 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (107 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 2, 2019Class IITerminated

   One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

   Z-0832-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT HARM OR INCORRECT RESULTS. THE CUSTOMER REPORTED THAT THEIR CARDIOCHEK PLUS ANALYZER "KEEPS GETTING WARM TO TOUCH". THE REPORTED ANALYZER WAS BEING USED BEYOND IT'S RECOMMENDED DEVICE LIFE AT THE TIME THE INCIDENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650626 ↗
• MalfunctionJan 14, 2026Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM OR INCORRECT RESULTS. REPORT BEING FILED OUT OF AN ABUNDANCE OF CAUTION. THE CUSTOMER REPORTED THAT THEIR CARDIOCHEK PLUS ANALYZER "SMELLS LIKE BURNING/SMOKING AS THOUGH THERE IS AN ELECTRICAL FAILURE". THE CUSTOMER DID NOT REPORT THAT THEIR ANALYZER GOT HOT/WARM TO TOUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077237 ↗
• MalfunctionOct 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM OR INACCURATE RESULTS. THE CUSTOMER REPORTED THAT "TWO BATTERIES WERE MELTED TOGETHER AND THEY WERE WARM." CONTACT CONFIRMED THERE WAS NO FLAME/FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363720 ↗
• MalfunctionAug 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THE CUSTOMER REPORTED THAT "A BATTERY MELTED IN THE BACK OF THE REPORTED ANALYZER, CAUSING IT TO GET HOT TO THE TOUCH." CONTACT ALSO REPORTED BURNING SMELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881462 ↗
• MalfunctionJun 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  CONTACT STATED THAT WHEN BATTERIES ARE INSERTED INTO THEIR CARDIOCHEK PLUS IT GETS HOT TO THE TOUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215198 ↗
• MalfunctionJun 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT OR USER HARM. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION. THE CUSTOMER USED THE VERBIAGE "THE BATTERY EXPLODED INSIDE THE ANALYZER" TO DESCRIBE AN EVENT IN WHICH "THE PHARMACY WAS ATTEMPTING TO RUN ROUTINE QC ON ANALYZER TODAY WHICH WOULDN'T TURN ON SO THEY OPENED THE COMPARTMENT DOOR AND NOTICED THAT A BATTERY HAD SPLIT OPEN IN THE ANALYZER." THIS ANALYZER WAS BEING USED BEYOND IT'S RECOMMENDED DEVICE LIFE AND THE CUSTOMER REPORTED THAT THEY WERE NOT FOLLOWING PROPER STORAGE PROCEDURES FOUND IN THE USER GUIDE (PS-004561-EN REV 6), WHICH STATES THAT BATTERIES SHOULD BE REMOVED WHEN CARDIOCHEK ANALYZERS ARE NOT IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163831 ↗
• MalfunctionJan 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT, WHEN BATTERIES ARE INSERTED, "IT BEGINS HEATING UP" AND "GETS SUPER HOT QUICKLY". THERE WAS NO ALLEGATION OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117935 ↗
• MalfunctionNov 12, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR ANALYZER GETS HOT WHEN USING. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662256 ↗
• MalfunctionOct 24, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT WHEN INSERTING NEW BATTERIES INTO THEIR ANALYZER, THE BATTERIES "GOT HOT, OVERHEATED, AND SPLIT (LIKELY REFERRING TO THE PLASTIC BATTERY LABEL)." THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525726 ↗
• MalfunctionOct 17, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR ANALYZER WOULD GET VERY HOT OVER TIME AFTER REPLACING THE BATTERIES. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470756 ↗
• MalfunctionAug 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR CARDIOCHEK PLUS ANALYZER "BEGAN TO OVERHEAT AND THE BATTERY EXPLODED." THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053917 ↗
• MalfunctionJul 3, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR CARDIOCHEK PLUS ANALYZER WOULD GET HOT AFTER USE AND WOULD THEN DISPLAY "HI TEMP". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670296 ↗
• MalfunctionJun 19, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE INSERTED BATTERIES WERE WARM TO THE TOUCH AND WHILE ATTEMPTING TO TAKE THEM OUT, THEY GOT BATTERY ACID ON THEIR FACE. THE CUSTOMER REPORTED THAT THEY WERE NOT SERIOUSLY HURT AND DID NOT REQUIRE MEDICAL INTERVENTION. DURING FOLLOW-UP A WEEK LATER, THE CUSTOMER FURTHER SUPPORTED THEY WERE NOT HURT, DID NOT REQUIRE ANY HOSPITALIZATION, AND WERE ABLE TO REMEDY THE EVENT WITH WASHING OF THE FACE WITH SOAP AND WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567971 ↗
• MalfunctionJun 19, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR BATTERIES MELTED UPON INSERTION INTO THEIR CARDIOCHEK PLUS ANALYZER. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567970 ↗
• MalfunctionJan 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR CARDIOCHEK PLUS ANALYZER IS OVERHEATING WITH INSTALLATION OF NEW BATTERIES. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495200 ↗
• MalfunctionNov 21, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THEIR ANALYZER "GOT VERY WARM AND HOT" PRIOR TO ATTEMPTING TESTING FOR THE DAY. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187148 ↗
• MalfunctionNov 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED HAVING THREE CARDIOCHEK PLUS ANALYZERS THAT WERE "OVERHEATING AND NOT WORKING". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS IS THE THIRD OF THREE SUBMISSIONS (ONE FOR EACH ANALYZER ALLEGATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18114937 ↗
• MalfunctionNov 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED HAVING THREE CARDIOCHEK PLUS ANALYZERS THAT WERE "OVERHEATING AND NOT WORKING". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS IS THE FIRST OF THREE SUBMISSIONS (ONE FOR EACH ANALYZER ALLEGATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110590 ↗
• MalfunctionNov 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED HAVING THREE CARDIOCHEK PLUS ANALYZERS THAT WERE "OVERHEATING AND NOT WORKING". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS IS THE SECOND OF THREE SUBMISSIONS (ONE FOR EACH ANALYZER ALLEGATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110589 ↗
• MalfunctionOct 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THEIR CARDIOCHEK PLUS ANALYZER WAS OVERHEATING. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010323 ↗
• MalfunctionOct 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THEIR CARDIOCHEK PLUS ANALYZER WAS OVERHEATING. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010321 ↗
• MalfunctionOct 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THEIR CARDIOCHEK PLUS ANALYZER WAS OVERHEATING. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010320 ↗
• MalfunctionOct 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT "THE BATTERIES WERE GETTING HOT IN THE ANALYZER". THE CUSTOMER REPORTED THIS OCCURING THE DAY BEFORE AND THE DAY OF COMMUNICATION OF THE ALLEGATION TO PTS. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930151 ↗
• MalfunctionOct 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED WHEN INSERTING BATTERIES INTO THEIR ANALYZER, THAT TWO OF THE BATTERIES BECAME VERY HOT AND THAT "THEY COULDN'T TOUCH THEM". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930150 ↗
• MalfunctionAug 4, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE BATTERY COMPARTMENT "BECAME VERY HOT" AFTER CHANGING THE BATTERIES. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17458197 ↗