Siemens epoc BGEM BUN Test Card Recall Due to Inaccurate Results
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Siemens Healthcare Diagnostics is recalling certain lots of the epoc BGEM BUN Test Card due to potential discrepant low pH and mTCO2 results, which could lead to misdiagnosis or inappropriate treatment.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
What Happened
The recall is due to the affected product potentially producing discrepant low pH and measured Total Carbon Dioxide (mTCO2) results in patient samples, which could lead to inappropriate treatment of nonexistent acidosis or missed diagnosis of alkalosis.
Which Products Are Affected
The affected product is the epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, with Siemens Material Number (SMN): 10736515, UDI-DI: 00809708121860, and lot numbers: 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70 (OUS only), 02-26027-80, 02-26028-80 (OUS only). A total of 71,725 units are affected, including 38,025 in the US, with distribution in the United States nationwide and other countries.
What You Should Do
Consumers should check if they have the affected lots and stop using the product, then contact Siemens Healthcare Diagnostics Inc as they were notified via letter for further instructions on returns or refunds.
Why This Matters
This recall affects medical devices used in patient care, potentially leading to incorrect diagnoses and treatments that could harm individuals.
Source
This recall information is from the FDA, recall number Z-2005-2026, event ID 98680. For more details, visit the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,258 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.