EPOC READER HR-1002-00-00Recalls & reported problems
Epocal Inc · EPOC READER · Class 2
Quick summary
This Epocal EPOC Reader test device has 87 reports in the FDA database, including 11 deaths and no injuries. Many reports describe results that differ from repeat testing, often low pH readings, and some describe readings that could not be reproduced. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 88
- Deaths reported
- 11
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00809708016685), received between Oct 29, 2019 and Sep 14, 2026 — classified as 11 deaths, 77 malfunctions.
The most frequently reported specific device problem is “High Test Results” (28 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- High Test Results28
- Low Test Results28
- Non Reproducible Results14
- No Device Output7
- Incorrect, Inadequate or Imprecise Result or Readings6
- Insufficient Device Problem Information3
- Smoking2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Insufficient Information8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
- Abnormal Blood Gases1
- Premature Labor1
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Low Test Results
The customer reported discrepant low creatinine when compared repeat testing of different samples on a comparative instrument and epoc. There is no report of injury due to this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752796 ↗MalfunctionApr 28, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH ON MULTIPLE PATIENTS WHEN COMPARED TO REPEAT TESTING ON A COMPARATIVE INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017979 ↗MalfunctionApr 27, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH ON TWO PATIENTS WHICH RESULTED IN THE PATIENTS BEING TAKEN OFF OF A VENTILATOR. THE CUSTOMER HAS NOT INDICATED IF THIS CHANGE WAS NECESSARY OR UNNECESSARY. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25007960 ↗MalfunctionApr 22, 2026High Test Results
THE CUSTOMER REPORTED DISCREPANT HIGH PO2 WHEN COMPARED TO REPEAT TESTING OF A NEW 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 24957763 ↗MalfunctionApr 22, 2026High Test Results
THE CUSTOMER REPORTED DISCREPANT HIGH PH WHEN COMPARED TO REPEAT TESTING OF A NEW 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 24957580 ↗MalfunctionApr 22, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS WHEN USING ONE TEST CARD LOT ON MULTIPLE EPOC INSTRUMENTS WHEN COMPARED TO REPEAT TESTING OF A DIFFERENT CARD LOT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955902 ↗MalfunctionApr 22, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS WHEN USING ONE TEST CARD LOT ON MULTIPLE EPOC INSTRUMENTS WHEN COMPARED TO REPEAT TESTING OF A DIFFERENT CARD LOT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955898 ↗MalfunctionApr 21, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS ON PATIENT(S). THE CUSTOMER INDICATED THAT TREATMENT WAS PROVIDED AND THAT UMBILICAL ARTERIAL AND VENOUS CATHETERS WERE THEN PLACED FOR SERIAL TESTING. NO INFORMATION WAS PROVIDED REGARDING THE SPECIFIC PATIENT(S) INVOLVED OR THE NUMBER OF INSTANCES IN WHICH THIS SAMPLING APPROACH WAS USED. NO RESULTS PROVIDED FOR THE SPECIFIC EVENT(S). THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938338 ↗MalfunctionApr 15, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS WHEN COMPARED TO THE EXPECTED PH VALUES FOR THE PATIENTS. NO REPEAT TESTING WAS PERFORMED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886445 ↗MalfunctionApr 15, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS WHEN COMPARED TO THE EXPECTED PH VALUES FOR THE PATIENTS. NO REPEAT TESTING WAS PERFORMED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886365 ↗MalfunctionApr 14, 2026Low Test Results
THE CUSTOMER REPORTED A DISCREPANT LOW PH RESULT WHEN COMPARED TO REPEAT TESTING ON A LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875055 ↗MalfunctionApr 14, 2026Low Test Results
THE CUSTOMER REPORTED A DISCREPANT LOW PH RESULT WHEN COMPARED TO REPEAT TESTING ON A LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874715 ↗MalfunctionApr 14, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS WHEN COMPARED TO REPEAT TESTING ON THE SAME AND A DIFFERENT EPOC INSTRUMENT WITH A DIFFERENT CARD LOT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873531 ↗MalfunctionApr 14, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS WHEN COMPARED TO REPEAT TESTING ON A COMPARATIVE DEVICE OR AGAINST AN EXPECTED NORMAL VALUE IF NO REPEAT TESTING WAS PERFORMED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872100 ↗MalfunctionApr 14, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH RESULTS WHEN COMPARED TO REPEAT TESTING ON A COMPARATIVE DEVICE OR AGAINST AN EXPECTED NORMAL VALUE IF NO REPEAT TESTING WAS PERFORMED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871096 ↗MalfunctionApr 10, 2026Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW PH WHEN COMPARED TO REPEAT TESTING ON A LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839928 ↗DeathApr 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT A PATIENT WAS UNDER DISTRESS AND UNSTABLE IN THE ER AND WAS BEING PREPARED FOR TRANSPORT TO ANOTHER FACILITY. A PH OF 6.940 WAS OBTAINED ON EPOC WITH A SAMPLE THAT WAS DIFFICULT TO OBTAIN. THE PATIENT WAS PROVIDED BICARBONATE. THE PATIENT CODED AND WAS UNABLE TO BE REVIVED FROM PULSELESS ELECTRICAL ACTIVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831895 ↗MalfunctionMar 25, 2026Low Test Results
THE CUSTOMER REPORTED A DISCREPANT LOW PH RESULT WHEN COMPARED TO REPEAT TESTING ON THE SAME INSTRUMENT WITH A DIFFERENT TEST CARD LOT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT. PLEASE SEE MDR#3002637618-2026-00024 FOR EVENT ON READER SN (B)(6) ON THE SAME PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689058 ↗MalfunctionMar 13, 2026High Test Results
THE CUSTOMER REPORTED DISCREPANT HIGH HEMOGLOBIN (AND HEMATOCRIT) WHEN COMPARED TO REPEAT TESTING OF A NEW SAMPLE ON A COMPARATIVE INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594123 ↗DeathNov 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REQUESTED A REVIEW OF INSTRUMENT PERFORMANCE TO AID IN THEIR MORBIDITY AND MORTALITY REVIEW CASE. THE CUSTOMER IS NOT ALLEGING THAT THE EPOC INSTRUMENT CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. THE CUSTOMER STATED NO CLINICAL DECISIONS WERE MADE WITH THE RESULTS OBTAINED FROM THE EPOC. THE PHYSICIAN HAD A RESULT FROM A DIFFERENT INSTRUMENT WITHIN 10 MINUTES AND THEIR DECISIONS WERE BASED ON THAT ANALYSIS. RESULTS, PATIENT DEMOGRAPHICS, DATE OF EVENT, DEVICE SERIAL NUMBER, AND DETAILS SURROUNDING THE EVENT ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23497462 ↗MalfunctionOct 15, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED DISCREPANT LOW HEMATOCRIT WHEN COMPARED TO REPEAT TESTING OF A SAMPLE FROM THE SAME DRAW ON A DIFFERENT INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300785 ↗MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED DISCREPANT A PCO2 RESULT ON A PATIENT WHEN COMPARED TO REPEAT TESTING OF DIFFERENT SAMPLES ON THE SAME INSTRUMENT. THE CUSTOMER NOTED THAT THERE WAS A POSSIBLE CONTAMINATION WITH TOTAL PARENTERAL NUTRITION TO THE DRAW SITE FOR THE DISCREPANT RESULT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23094457 ↗MalfunctionAug 1, 2025High Test Results; High Test Results
THE CUSTOMER REPORTED DISCREPANT HIGH PCO2 WHEN COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON A DIFFERENT INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22688485 ↗DeathJul 18, 2025Low Test Results; Low Test Results
UPDATE AUGUST 2025: THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT LOW HCO3 RESULT ON A SINCE DECEASED PATIENT THAT DID NOT MATCH CLINICAL PICTURE OF THE PATIENT. THE EXPECTED VALUES CORRESPONDED WITH THE REFERENCE RANGES. THE PATIENT CAME IN FOR PULSELESS ELECTRICAL ACTIVITY ARREST. THERE ARE NO ALLEGATIONS OF UNNECESSARY TREATMENT OR PROCEDURES BEING PERFORMED, NO DELAYED NECESSARY TREATMENTS, AND NO HARM BEING CAUSED RELATED TO THE DEVICE. NOTE THIS IS THE SAME PATIENT AS MDR 3002637618-2025-00055. THIS IS FOR THE OTHER INSTRUMENT.
Patient problems: Insufficient Information
MAUDE report 22545885 ↗DeathJul 18, 2025High Test Results; Imprecise or Erratic Results; High Test Results; Imprecise or Erratic Results
UPDATE AUGUST 2025: THE CUSTOMER REPORTED DISCREPANT HIGH AND LOW HCO3 (CALCULATED FROM PH AND PCO2) ON A SINCE DECEASED PATIENT THAT DID NOT MATCH CLINICAL PICTURE OF THE PATIENT. THE EXPECTED VALUES CORRESPONDED WITH THE REFERENCE RANGES. THE PATIENT CAME IN FOR PULSELESS ELECTRICAL ACTIVITY ARREST. THERE ARE NO ALLEGATIONS OF UNNECESSARY TREATMENT OR PROCEDURES BEING PERFORMED, NO DELAYED NECESSARY TREATMENTS, AND NO HARM BEING CAUSED RELATED TO THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 22544188 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.