Siemens ADVIA Centaur Cleaning Solution Recalled for Stability Concerns
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cleaning Solution because its stability is not assured. The product is used in in vitro diagnostic systems.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a stability concern without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur and ADVIA Centaur XP and CP Cleaning Solution (Catalog Number 112748). The recall is issued because the stability of the cleaning solution is not assured. This product is a component used for in vitro diagnostic purposes with the ADVIA Centaur systems and does not have independent Instructions for Use.
The affected product was distributed worldwide, including nationwide in the United States and internationally to Canada, Great Britain, Saudi Arabia, Nepal, and Viet Nam. The specific lot numbers involved are 459356 and 443105, both with an expiration date of November 2014. The quantity recalled is 4,645 units (12 pk).
Users of the ADVIA Centaur systems should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to Siemens Healthcare Diagnostics, Inc. according to their instructions.
The recalled product
- Product
- ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA…
- 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 (2)
- Lot Numbers: 459356 Exp. Date: November 2014
- 443105 Exp. Date: November 2014
Distribution
Distributed nationwide across the United States.
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