[pending] Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Pending LLM rewrite. Source: FDA_DEVICE Z-1551-2025.
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
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
The recalled product
- Product
- Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
- 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 (3)
- Siemens Material Number (SMN): 11537223
- UDI-DI: 00630414610887
- Lot numbers: All lots.
Distribution
Distributed nationwide across the United States.
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