CardioChekRecalls & reported problems across all models

We found 3 models of CardioChek by Henry Schein, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, 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).

3 FDA recall records 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 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-0835-2020 · Root cause: Device Design · Recall details · FDA record ↗

2. 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-0834-2020 · Root cause: Device Design · Recall details · FDA record ↗

3. Jun 7, 2019Terminated

   The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901

   Z-2158-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported CardioChek problems

CardioChek models

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

• CardioChek 5700411

  ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
  1 recall5 reports
• CardioChek 5700534

  TUBE, COLLECTION, CAPILLARY BLOOD
  1 recall0 reports
• CardioChek 5700414

  LDL & VLDL PRECIPITATION, HDL
  1 recall0 reports

Recent CardioChek adverse event reports

The 5 most recent reports across all models, 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 ↗

Other Henry Schein, Inc. products

• Criterion2 models · 1 reports · 1 recall
• Henry Schein Maxima3 models · 20 reports