EPOC READER, REFURBISHED, ROHS COMPLIANT HR-1R04-00-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00809708116712), received between May 11, 2023 and Apr 15, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Low Test Results

  THE CUSTOMER REPORTED DISCREPANT LOW PH WHEN COMPARED TO REPEAT TESTING ON OTHER EPOC INSTRUMENTS AND TEST CARD LOTS. THERE IS NO REPORT OF INJURY DO TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884245 ↗
• MalfunctionMar 25, 2026Low Test Results

  THE CUSTOMER REPORTED A DISCREPANT LOW PH RESULT WHEN COMPARED TO REPEAT TESTING ON A DIFFERENT EPOC INSTRUMENT WITH A DIFFERENT TEST CARD LOT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688844 ↗
• MalfunctionAug 5, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT HIGH POTASSIUM WHEN COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON A LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713915 ↗
• MalfunctionFeb 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT HIGH PH ON ONE PATIENT WHEN COMPARED TO REPEAT TESTING ON THE SAME INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434709 ↗
• MalfunctionFeb 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT HIGH PH ON ONE PATIENT WHEN COMPARED TO REPEAT TESTING ON A NEW EPOC INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433223 ↗
• MalfunctionNov 21, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A DISCREPANT LOW CREATININE RESULT COMPARED TO RETESTING OF THE SAME? SAMPLE ON THEIR LABORATORY INSTRUMENT. CUSTOMER STATED THAT THE LEVEL 1 QC FAILED LOW FOR CREATININE ON (B)(6). THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181492 ↗
• MalfunctionOct 4, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEIR EPOC INSTRUMENT GAVE A DISCREPANT HIGH HEMATOCRIT (HCT) RESULT COMPARED TO RETESTING OF A NEW SAMPLE ON A LAB INSTRUMENT. HEMOGLOBIN, WHICH EPOC CALCULATES FROM THE HEMATOCRIT READING, WAS ALSO NOTED TO BE DISCREPANTLY HIGH. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869268 ↗
• MalfunctionMay 12, 2023High Test Results; High Test Results

  THE CUSTOMER IS ALLEGING RECEIVING DISCREPANT HIGH CHGB AND HCT ON A PATIENT FROM SIEMENS EPOC DEVICE AS COMPARED TO NON-SIEMENS INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921414 ↗
• MalfunctionMay 11, 2023High Test Results; High Test Results

  THE CUSTOMER IS ALLEGING RECEIVING DISCREPANT HIGH CHGB AND HCT ON A PATIENT FROM SIEMENS EPOC DEVICE AS COMPARED TO NON-SIEMENS INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913914 ↗