CardioChek® Plus Professional Analyzer 2701Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00381932701013), received between Jan 7, 2020 and Nov 25, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (9 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, 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 24, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED A CARDIOCHEK PLUS ANALYZER WHICH WAS WARM TO THE TOUCH IN THE BATTERY AREA AFTER NEW BATTERY INSERTION. 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 19392259 ↗
• MalfunctionJul 28, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THE ANALYZER WAS "WARM TO THE TOUCH". THE CUSTOMER REPORTED THE ANALYZER WOULD TURN OFF UPON FEELING WARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412857 ↗
• MalfunctionAug 25, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT WHEN REMOVING THE LAST BATTERY FROM THE BATTERY COMPARTMENT THAT THE ANALYZER WAS "EXTREMELY HOT", THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10449914 ↗
• MalfunctionAug 25, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED WHEN REMOVING THE LAST BATTERY FROM THE BATTERY COMPARTMENT THAT THE BATTERY WAS "EXTREMELY HOT". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10449908 ↗
• MalfunctionAug 25, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE LAST BATTERY REMOVED FROM THE BATTERY COMPARTMENT WAS "EXTREMELY HOT". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10449896 ↗
• MalfunctionJan 7, 2020Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECEIVING HIGH CONTROL RESULTS THAT WERE OUTSIDE THE CONTROL RANGE WHEN TESTING EGLU. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557354 ↗