Siemens Epoc Test Cards: Potential for High Glucose Errors in Low-Range Results
Siemens Healthcare recalls specific epoc test cards that may show falsely high glucose levels for samples near the lower end of the reportable range. Affected units include certain software versions and lot numbers with expiry dates through August 2023.
Lower-risk recall
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Contact the company
What happened, in plain English
Siemens Healthcare is recalling epoc test cards that may show higher glucose results than actual for samples with glucose levels at the lower end of the reportable range. This could lead to incorrect diabetes management decisions if the test results are used without knowing the issue. Read more at govinfonow.com/recall/57911-siemens-epoc-test-cards-potential-for-high-glucose-errors-in.
Source Summary by GovInfoNow · govinfonow.com/recall/57911-siemens-epoc-test-cards-potential-for-high-glucose-errors-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2477-2023
Cite this page
“Siemens Epoc Test Cards: Potential for High Glucose Errors in Low-Range Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57911-siemens-epoc-test-cards-potential-for-high-glucose-errors-in. Based on FDA recall #Z-2477-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2477-2023%22&limit=1).
Why it’s dangerous
The test card software may misread glucose levels when results are near the lower limit of what the device can report. This could cause a false high reading, potentially leading to incorrect diabetes treatment decisions.
Who’s affected
People using Siemens epoc test cards with specific software versions and lot numbers (expiring through August 2023) are affected. Those managing diabetes with these test cards are most at risk.
How to tell if you have this one
Check for the model name 'epoc BGEM Crea Test Card' with software versions v3.37.3 (Host) and v4.10.6 (NXS), and lot numbers 03-23002-60 (expires June 19, 2023) or 03-23056-50 (expires August 12, 2023).
- Brand
Siemens Healthcare- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2476-2023 | epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1; UDI-DI: 00809708121860 Siemens Material Number: 10736515 Lots: 04-23003-60 (expiry 20-Jun-2023), 11-22337-60 (expiry 20-May-2023), 04-23034-40 (expiry 21-Jul-2023), 04-23059-50 (expiry 15-Aug-2023), 04-23059-60 (expiry 15-Aug-2023), and 04-23069-40 (expiry 25-Aug-2023) | 3201 ea |
| Z-2477-2023 | epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1; UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023) | 473 ea |
| Z-2478-2023 | epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1; UDI-DI: 00630414243788 Siemens Material Number: 10736516 Lots: 04-23043-51 (expiry 30-Jul-2023) | 348 ea |
What to do — step by step
Check Your Test Card
Look for the model name 'epoc BGEM Crea Test Card' with specific software versions and lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in 25 states and D.C., and outside the U.S.
FDA distribution: “US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these test cards?
The recall does not require stopping use; it only identifies a potential for inaccurate results. You can continue using the test cards but should verify results with a different method if concerns arise.
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Where this comes from
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-2477-2023 (June 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2477-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.