CardioChek Plus Professional AnalyzerRecalls & reported problems across all models

We found 2 models of CardioChek Plus Professional Analyzer by Polymer Technology Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 124 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2019 and Mar 20, 2026 — classified as 124 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (116 reports).

1 FDA recall record name at least one of these models by its device 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. 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

CardioChek Plus Professional Analyzer recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 2, 2019Terminated

   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 CardioChek Plus Professional Analyzer problems

CardioChek Plus Professional Analyzer models

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

• CardioChek® Plus Professional Analyzer 2700

  LDL & VLDL PRECIPITATION, HDL
  1 recall114 reports
• CardioChek® Plus Professional Analyzer 2701

  SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
  10 reports

Recent CardioChek Plus Professional Analyzer adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionNov 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. THE CUSTOMER REPORTED THAT THE REPORTED ANALYZER BECAME WARM TO TOUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641291 ↗
• 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 ↗
• MalfunctionAug 14, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT OR USER HARM. THE CUSTOMER REPORTED THAT UPON BATTERY INSTALLATION, THEIR ANALYZER'S BATTERY COMPARTMENT "GOT REALLY HOT AND BRAND-NEW BATTERIES EXPLODED AFTER REMOVING THEM FROM THE ANALYZER. NO ONE WAS INJURED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812871 ↗
• MalfunctionJun 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE RETURNED ANALYZER BEGAN TO GET WARM UPON BATTERY INSTALLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301472 ↗
• 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 ↗
• MalfunctionMay 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THERE WERE NO ALLEGATIONS OF PATIENT OR USER HARM. A PTS DIAGNOSTICS TECHNICAL SUPPORT SPECIALIST REPORTED THAT AN ANALYZER BECAME WARM TO THE TOUCH UPON BATTERY INSTALLATION. THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120065 ↗
• 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 ↗