PTS Panels® CHOL+Glu Test Strips 1765Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00381931765016), received between Aug 13, 2022 and Jul 11, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

2 FDA recall records name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K162282); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 16, 2022Class IIICompleted

   Incorrect instructions for use were packaged into the final product.

   Z-1741-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Mar 14, 2018Class IITerminated

   Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

   Z-1543-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT TWO PATIENTS EXPERIENCED HIGH GLUCOSE RECOVERY WHEN TESTING WITH THE PRODUCT. ONE PATIENT REPORTED THAT THE VALUE WAS HIGH BUT IS UNSURE OF THEIR EXPECTED VALUE. THE SECOND PATIENT REPORTED THE VALUE RECEIVED (241 MG/DL) WAS HIGH SO THEY TESTED THEMSELVES ON THEIR CGM THEY WERE WEARING AND RECEIVED 141 MG/DL. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19723732 ↗
• MalfunctionSep 29, 2023Low Readings; Low Readings

  THE CUSTOMER REPORTED RECEIVING HIGH CHOLESTEROL (OUT OF RANGE) AND LOW UNBELIEVABLE GLUCOSE RECOVERY. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THIS INCIDENT WILL BE REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE RETURNED ANALYZER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848419 ↗
• MalfunctionAug 13, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  THE CUSTOMER REPORTED THAT UPON INCOMING INSPECTION, THEY OBSERVED TWO CHOL+GLU LOT A202 BOXES HAD A CHOL+HDL PACKAGE INSERT INSTEAD. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARN. THERE WERE NO ALLEGATIONS OF INCORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222662 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162282. One submission often covers many models, so check the product and lot details in each record.

• Z-0741-2020 · Mar 15, 2016 · Terminated
  PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers