[pending] epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 1
Pending LLM rewrite. Source: FDA_DEVICE Z-1684-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
The recalled product
- Product
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Siemens Material Number (SMN): 10736515
- Udi-DI: 00809708121860
- Lot Numbers: All lot numbers with prefix (xx) 02 or 12
- epoc Software Version and Senor Configuration: epoc Host SW V3.41.2
- epoc NXS SW v4.14.9 & 4.14.11
- Sensor Configuration 45.n.
Distribution
Distributed nationwide across the United States.
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