EPOC BGEM BUN TEST CARD 10736515Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00809708121860), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.

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

6 FDA recall records name this device's identifier, 6 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. Apr 2, 2026Class IIOpen, Classified

   Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.

   Z-2005-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 7, 2025Class IIOpen, Classified

   Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.

   Z-2272-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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-1684-2025 · Root cause: Process control · Recall details · FDA record ↗

4. Sep 24, 2024Class IIOpen, Classified

   Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.

   Z-0286-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. 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-2476-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Jun 1, 2022Class IIOpen, Classified

   Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

   Z-1372-2022 · 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.

• MalfunctionNov 25, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED A DISCREPANT HEMATOCRIT RESULT ON A NEONATE ON THE EPOC READER WHEN COMPARED TO THE RESULT ON A NON-SIEMENS HEMATOLOGY INSTRUMENT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 10905601 ↗