EPOC BGEM CREA TEST CARD CT-1006-00-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00809708072254), received between Dec 1, 2017 and Dec 1, 2017 — classified as 1 death.

The most frequently reported specific device problem is “Device Operational Issue” (1 report).

2 FDA recall records name this device's identifier, 2 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

1. Mar 19, 2025Class IIOpen, Classified

   The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

   Z-1685-2025 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 1, 2023Class IIOpen, Classified

   There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

   Z-2477-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• DeathDec 1, 2017Use of Device Problem; Device Operational Issue; Use of Device Problem; Device Operational Issue

  IT WAS REPORTED TO EPOCAL ON (B)(6) 2017 (CASE NUMBER 00973317) THAT TWO "IQC SAMPLE DELIVERY" AND ONE "IQC INSUFFICIENT SAMPLE DETECTED" ERROR MESSAGES WERE DISPLAYED DURING TESTING ON A PATIENT EXPERIENCING A CODE MEDICAL EMERGENCY. THE PATIENT PASSED AWAY TWO DAYS LATER DUE TO THE CARDIORESPIRATORY EVENT THAT OCCURRED ON (B)(6) 2017. THE INITIAL REPORTER STATED: "POINT-OF-CARE COORDINATOR CALLED TO ASK THE CAUSES OF TWO TYPES OF IQC FAILURES: SAMPLE DELIVERY AND INSUFFICIENT SAMPLE DETECTED. THESE FAILURES BEGAN (B)(6) 2017 AND CUSTOMER WENT TO THE ICU TO RUN SOME SAMPLES AS PRELIMINARY TROUBLESHOOTING. CUSTOMER ALSO RAN QC WHICH RESULTED FINE. DURING THE PHONE CALL, CUSTOMER MENTIONED EPOC SAMPLE DELIVERY IQC FAILURES OCCURRED DURING PATIENT CODE ON (B)(6) 2017. CALLER WAS NOT THE TEST OPERATOR. TWO OPERATORS RAN THE EPOC SYSTEM. -PATIENT ID:(B)(6). -PATIENTS' AGE AND MEDICAL HISTORY: DATE OF BIRTH=(B)(6), MALE, (B)(6), DOWN'S SYNDROME, HEART FAILURES AND DEFECTS. -PATIENTS' MEDICAL SYMPTOMS? NOT BREATHING (TIME NOTED WAS NOT PROVIDED). CHRONOLOGY: (B)(6) 2017. A CODE WAS CALLED. THE CUSTOMER ESTIMATED THE TIME TO BE 13:55, BUT THEY COULDN'T CONFIRM: 1:55PM: THE NC WAS REMOVED.

  Patient problems: Death

  MAUDE report 7076683 ↗