EPOC READER, REFURBISHED HR-1R02-00-00Recalls & reported problems
Epocal Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00809708032333), received between Mar 1, 2019 and Mar 26, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 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.
Reports received per month
Most reported problems
Device problems
- High Test Results2
- Low Test Results2
- Non Reproducible Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED DISCREPANT HIGH PH RESULTS ON A PATIENT ON TWO DIFFERENT SAMPLES WHEN COMPARED TO REPEAT TESTING ON TWO DIFFERENT EPOC INSTRUMENTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696733 ↗MalfunctionMar 26, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED DISCREPANT HIGH PH ON A PATIENT WHEN COMPARED TO REPEAT TESTING ON A NEW SAMPLE ON TWO EPOC INSTRUMENTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696485 ↗MalfunctionOct 31, 2024Low Test Results; Low Test Results
THE CUSTOMER REPORTED THAT THEY RECEIVED SEVERAL DISCREPANT LOW HEMATOCRIT )HCT) RESULTS COMPARED TO RETESTING OF NEW SAMPLES ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF HARM DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579610 ↗MalfunctionJul 13, 2022Low Test Results; Low Test Results
THE CUSTOMER REPORTED THAT THEIR EPOC INSTRUMENT GAVE A DISCREPANT LOW SODIUM RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON A NON-SIEMENS INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15007170 ↗MalfunctionJul 17, 2020Non Reproducible Results; Non Reproducible Results
THE CUSTOMER RECEIVED DISCREPANT ELEVATED PO2 RESULTS ON TWO PATIENTS COMPARED TO RETESTING ON ANOTHER EPOC INSTRUMENT USING THE SAME SAMPLES. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10290348 ↗MalfunctionMar 1, 2019Non Reproducible Results; Non Reproducible Results
THE CUSTOMER REPORTED DISCREPANT HEMOGLOBIN RESULTS ON THE EPOC BLOOD ANALYSIS SYSTEM WHEN COMPARED TO TWO NON-SIEMENS HEMATOLOGY LAB ANALYZERS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8384067 ↗
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- cobas b 221 <6> system 3337154001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, POTASSIUM1 recall43 reports
- EPOC READER HR-1002-00-00Epocal Inc · Electrode, Ion Specific, Potassium11 deaths88 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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