Siemens Healthcare Diagnostics Inc: Device Recall
Recall #Z-0286-2025 · 09/24/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0286-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Status
- Ongoing
- Date Initiated
- 09/24/2024
- Location
- Norwood, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1292 units
Reason for 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.
Product Description
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Distribution Pattern
US Nationwide. Canada.
Other Recalls by Siemens Healthcare Diagnostics Inc
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 10/06/2025
- Class II: Risk 09/22/2025
- Class II: Risk 08/11/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.