Lower riskMedical device recall · FDA · Published September 24, 2024
Siemens Healthcare Epoc BUN Test Cards Recall: Negative Sodium Bias Risk
Siemens Healthcare recalls epoc BGEM BUN Test Cards with potential negative sodium bias that could affect blood test accuracy. No injuries reported, but affected lots expired before recall.
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.
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics Inc2 Edgewater Dr · Norwood, MA 02062-4637
“Siemens Healthcare Epoc BUN Test Cards Recall: Negative Sodium Bias Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53874-siemens-healthcare-epoc-bun-test-cards-recall-negative-sodium-bias. Based on FDA recall #Z-0286-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2025%22&limit=1).
Siemens Healthcare Diagnostics Inc. recalled epoc BGEM BUN Test Cards for the epoc Blood Analysis System on Sept. 24, 2024, due to a potential negative sodium bias in one lot, according to the FDA. The company initiated this voluntary Class II recall after confirming the issue in internal testing.
How to tell if you have it
Brand: Siemens Healthcare
Product: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
SMN: 10736515
UDI-DI: 00809708121860
Lot Numbers: 08-24092-60, 08-24093-60, 08-24094-60, 08-24095-60, 08-24096-60
Quantity: 1292 units
Distribution: US Nationwide and Canada
The hazard
The recall addresses a negative sodium bias that may exist in the test cards approximately two months prior to expiration, with an observed maximum negative bias of -10 mmol/L from internal testing. One customer complaint has been associated with this issue, but no adverse events have been reported. Quality Control fluid may or may not detect the issue depending on the bias magnitude and testing frequency.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Recent brand-specific recalls include the Atellica CH RCRP Test recall from Aug. 17, 2026, and the Atellica CH Urine Albumin Recall from July 6, 2026. Other recent recalls of similar products include the Vivoo Test Strips Recall (Nov. 22, 2025), the AVID Medical Haylard 18G Epi Tray Recall (Aug. 10, 2026), and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check for lot numbers 08-24092-60 through 08-24096-60 on the test card packaging. The test cards are for the epoc Blood Analysis System and expired before the recall was issued.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Card Lot Number
Look for lot numbers 08-24092-60 through 08-24096-60 on the test card packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide. Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0286-2025 (September 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0286-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.