CardioChek® Plus Professional Analyzer, Refurbished 2702Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00381932702010), received between Aug 25, 2020 and Jun 14, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 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-0833-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE BATTERIES IN THEIR CARDIOCHEK PLUS ANALYZER "GOT VERY HOT AND MELTED". 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 19536414 ↗
• MalfunctionApr 7, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER PROVIDED A LOG SHEET OF 6 ANALYZERS WITH THE SAME COMPLAINT DESCRIPTION. ALL 6 ANALYZERS HAVE THE SAME ALLEGATION, "THE ANALYZER GOT VERY HOT AND NOW THERE IS CORROSION". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM FOR ANY OF THE REPORTED INCIDENTS. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. EACH ANALYZER WILL RECEIVE ITS OWN MEDWATCH FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704322 ↗
• MalfunctionApr 7, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER PROVIDED A LOG SHEET OF 6 ANALYZERS WITH THE SAME COMPLAINT DESCRIPTION. ALL 6 ANALYZERS HAVE THE SAME ALLEGATION, "THE ANALYZER GOT VERY HOT AND NOW THERE IS CORROSION". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM FOR ANY OF THE REPORTED INCIDENTS. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS. EACH ANALYZER WILL RECEIVE ITS OWN MEDWATCH FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704317 ↗
• MalfunctionMar 11, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE ANALYZER STARTED OVERHEATING UPON REPLACING THE BATTERIES. THERE WAS NO ALLEGATION OF PATIENT/USER HARM. THERE WAS NO ALLEGATION OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11461895 ↗
• MalfunctionAug 25, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED WHEN RUNNING CONTROLS THAT THE ANALYZER STARTED TO "GET HOT". THE CUSTOMER OPENED THE BATTERY COMPARTMENT TO REMOVE THE BATTERIES AND STATED THEY WERE "REALLY HOT". THERE WAS NO ALLEGATION OF PATIENT/USER HARM. THERE WAS NO ALLEGATION OF INCORRECT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10447976 ↗