epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis… recallZ-0286-2025 · Siemens Healthcare Diagnostics Inc · initiated Sep 24, 2024
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
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.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Correction letter dated September 2024 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " If you are a distributor, please ensure your customers receive this UMDC letter. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of the affected products listed in the above table may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " For any questions, you may call Siemens Healthineers Technical Solutions Center at 877-229-3711.
Recall details
- Recall number
- Z-0286-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 24, 2024
- Posted by the FDA
- Nov 1, 2024
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 1292 units
- Product code
- CHL
- FDA submissions
- K200107
- Distribution
- US Nationwide. Canada.
Product description
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Code information (models, lots, serial numbers)
UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60
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
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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