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epoc Host2 11413524Recalls & reported problems

Epocal Inc · The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory orat the point of care in hospitals, nursing homes or other clinical care institutions. · Class 2

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 00630414606460), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K061597, K090109, K092849, K093297, K113726, K171247); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 12, 2022Open, Classified

    pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

    Z-1214-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • High Test Results1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 4, 2022High Test Results; High Test Results

    THE CUSTOMER REPORTED THAT THEIR EPOC INSTRUMENT GAVE A DISCREPANT HIGH 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 15729710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061597, K090109, K092849, K093297, K113726, K171247. One submission often covers many models, so check the product and lot details in each record.

  • Z-1971-2013 · Mar 13, 2013 · Terminated
    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
  • Z-2034-2012 · Jun 28, 2011 · Terminated
    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Anal
  • Z-1287-2011 · Oct 27, 2010 · Terminated
    02.122.585, 85mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and
  • Z-0952-2009 · Oct 16, 2008 · Terminated
    EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood

Other ELECTRODE, ION SPECIFIC, CALCIUM devices

All ELECTRODE, ION SPECIFIC, CALCIUM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.