HOST 2, EPOC, JAPANESE HH-1009-JP-JPRecalls & reported problems
Epocal Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00809708075576), received between Nov 11, 2019 and Nov 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
- Dec 12, 2022Class IIOpen, Classified
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Z-1214-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2019Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THE EPOC BARCODE READER MIS-SCANNED THE PATIENT ID AND RESULTS FROM PATIENT #1 WERE SENT TO PATIENT #2. PATIENT #2 DID NOT HAVE THESE TESTS ON THIS DAY. THE CUSTOMER NOTICED THE ERROR AND RERAN PATIENT #1. REPEAT TEST RESULTS WERE SENT TO THE CORRECT PATIENT (PATIENT #1). THERE WAS NO REPORT OF HARM OR INCORRECT TREATMENT TO EITHER PATIENT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9306240 ↗
Other Electrode, Ion Specific, Potassium devices
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- Aptio Automation AP2Inpeco SA · Electrode, Ion Specific, Potassium5 recalls6 deaths16 reports
- Accelerator a3600 ACPInpeco SA · Electrode, Ion Specific, Potassium5 recalls13 reports
- FlexLab X FXXInpeco SA · Electrode, Ion Specific, Potassium2 recalls2 reports
- EPOC BGEM CREA TEST CARD CT-1006-00-00Epocal Inc · Electrode, Ion Specific, Potassium2 recalls1 death1 report
- 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
- cobas b 221 <4> system 3337138001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, POTASSIUM1 recall7 reports
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 · each recall links to the FDA recall notice
- 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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