EPOC BGEM TEST CARD CT-1004-00-00Recalls & reported problems
Epocal Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00809708047283), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 malfunction.
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
Device problems
- No Apparent Adverse Event1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2018No Apparent Adverse Event; No Apparent Adverse Event
A CUSTOMER FROM (B)(6) REPORTED (CASE (B)(4)) THAT THEIR IONIZED CALCIUM RESULTS ARE ALWAYS LESS THAN 1 MMOL/L AND THAT THEIR LACTATE VALUES ARE HIGH (E.G. 40, 65 MG/DL). THE CUSTOMER WAS USING EPOC TEST CARDS (CT-1004-00-00) LOT 02-17273-10 AND EPOC HOST (HH-1009-00-00) WITH S/N (B)(4). NO ADVERSE EVENT WAS REPORTED. CUSTOMER CONFIRMED THE PRODUCT WAS DISCARDED. THE INITIAL EVENT STATED: "LOCAL TECHNICAL SUPPORT TEAM VERIFIED THE COLLECTION: THE COLLECTION OF PATIENTS WITH LIQUID HEPARIN (WETS SYRINGE WITH HEPARIN AND EMPTIES) AND PERFORMS COLLECTION. RESULTS OBSERVED BY THE CUSTOMER FOR THE MAJORITY OF PATIENTS, IN VENOUS AND ARTERIAL SAMPLES. COMPARISON WITH OTHER EQUIPMENT WAS NOT PERFORMED AND RAW DATA WAS NOT AVAILABLE". ADDITIONAL RELEVANT INFORMATION SUCH AS PATIENT INFORMATION AND RESULTS WAS REQUESTED ON 20-FEB-2018 VIA COMPLAINT UPDATE ((B)(4)) IN THE COMPLAINTS HANDLING TOOL, BUT AFTER PERFORMING MULTIPLE ATTEMPTS THE LOCAL TECHNICAL SUPPORT TEAM COULD NOT GET ANY ADDITIONAL INFORMATION FROM THE CUSTOMER. ALTHOUGH EPOCAL DETERMINED ON 07-MAR-2018 THAT THIS COMPLAINT DOES NOT MEET THE REPORTABILITY CRITERIA, THE LOCAL ALERE/ABBOTT TECHNICAL SUPPORT TEAM IN (B)(4) DECIDED
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7723460 ↗
Other Electrode, Ion Specific, Potassium devices
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- 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
- 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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