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epoc BGEM BUN Test Card
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MEDICAL DEVICE RECALLMODERATE

epoc BGEM BUN Test Card

Siemens is recalling epoc BGEM BUN Test Cards due to inaccurate pH and mTCO2 results that could lead to improper patient treatment.

What to do

Healthcare providers should discontinue use of the affected test cards and contact Siemens Healthcare Diagnostics for further instructions regarding replacement or return.

Recalled
Listed
Updated
Recall No.
Z-2005-2026
Agency
FDA
Firm
Siemens Healthcare Diagnostics Inc
Recall ID
98680
Status
ONGOING

Recall at a glance

Quantity recalled
71725 (38025 US, 33700 OUS)

Why it was recalled

Siemens is recalling the epoc BGEM BUN Test Card used with the epoc Blood Analysis System due to a risk of discrepant low pH and measured Total Carbon Dioxide (mTCO2) results. These inaccurate readings may lead to the inappropriate treatment of nonexistent acidosis or the failure to diagnose alkalosis, potentially causing patient harm. This recall was distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

UDI-DI
10736515, 00809708121860

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification