Z-0286-2025 Class II Ongoing
FDA device recall Z-0286-2025 was initiated by Siemens Healthcare Diagnostics Inc on Sep 24, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1292 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 13, 2024
- Initiation Date
- Sep 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1292 units
Product Description
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
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.
Distribution Pattern
US Nationwide. Canada.
Code Information
UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0286-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026