epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS… recallZ-2476-2023 · Siemens Healthcare Diagnostics Inc · initiated Jun 1, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
FDA root cause category: Under Investigation by firm
What the company is doing
Consignees were notified via an Urgent Medical Device Correction letter beginning June 5, 2023. Consignees were informed of the issue and were provided a workaround and actions to take. The next sensor configuration/software version, sensor configuration 42.1/epoc Host SW v3.38.2 /epoc NXS SW v4.11.11, is available to customers in Siemens Healthineers Document Library or the epoc Live Update Service (eLUS). This next sensor configuration, 42.1, mitigates the issue.
Recall details
- Recall number
- Z-2476-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 1, 2023
- Posted by the FDA
- Aug 28, 2023
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 3201 ea
- Product code
- CHL
- FDA submissions
- K200107
- 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
Product description
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Code information (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EPOC BGEM BUN TEST CARD 10736515Epocal Inc6 recalls1 report
Other devices under the same FDA submission
1 device cleared under K200107 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- epoc NXS Host 11413475Epocal Inc · ACID, LACTIC, ENZYMATIC METHOD2 recalls6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92537).
- Z-2477-2023 · Open, Classifiedepoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Z-2478-2023 · Open, Classifiedepoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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