CardioChek 5700411Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00304040037713), received between Jul 22, 2019 and Jan 10, 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.

3 other recalls cover devices cleared under the same FDA submission (K140068); 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.

Recalls naming this device

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-0835-2020 · Root cause: Device Design · 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.

• MalfunctionJan 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER THAT THEIR CARDIOCHEK PLUS ANALYZER IS "HOT WHEN USED". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484431 ↗
• MalfunctionJan 7, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT WHEN THEY INSERT BATTERIES, THEIR ANALYZER "HEATS UP TO THE POINT OF SMOKING". 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 13193856 ↗
• MalfunctionJul 26, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT AFTER REPLACING THE BATTERIES THE ANALYZER WAS "VERY HOT." THE CUSTOMER ALSO STATED THAT TWO OF THE BATTERIES PLASTIC COATING HAD MELTED. 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 12226035 ↗
• MalfunctionFeb 12, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE ANALYZER IS "FRIED". UPON REPLACING THE BATTERIES, THE CUSTOMER STATED "IT HEATED UP AND THE BATTERIES EXPLODED". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WAS NO ALLEGATION OF INCORRECT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699197 ↗
• MalfunctionJul 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE ANALYZER WAS "INITIALLY GETTING HOT" WHEN THEY WENT BACK TO USE IT AGAIN IT "GOT EXTREMELY HOT". THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812244 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140068. One submission often covers many models, so check the product and lot details in each record.

• Z-0832-2020 · Dec 2, 2019 · Terminated
  PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
• Z-0833-2020 · Dec 2, 2019 · Terminated
  PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
• Z-0834-2020 · Dec 2, 2019 · Terminated
  Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036