Siemens ADVIA Centaur CP Immunoassay System Recalled for Documentation Errors
Siemens Healthcare Diagnostics is recalling the ADVIA Centaur CP Immunoassay System because inaccuracies in the Operator's Guide may cause sample processing issues when using EZee-Nest Insert Cups.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation error rather than a direct physical hazard.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur CP Immunoassay System (Siemens Material Number 10309710). This in vitro diagnostic (IVD) system is intended for professional use in a laboratory environment only.
The recall was initiated because the firm identified an issue in sample processing when using EZee-Nest Insert Cups. This issue stems from two inaccuracies present in the ADVIA Centaur CP Operator's Guide.
The recall affects 442 units in the United States and 3,237 units distributed worldwide. The affected units are distributed nationwide in the US and in numerous countries including Canada, the United Kingdom, Australia, and Germany. All serial numbers are affected. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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