Siemens ADVIA Centaur Multi-Diluent 1 Recalled for Decreased Dilution Recovery
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Multi-Diluent 1 because it may show decreased dilution recovery when stored on-board the system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the hazard is a performance issue (decreased dilution recovery) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Multi-Diluent 1, a reagent used for automated dilutions in the ADVIA Centaur BNP and TSH3 Ultra assays. The recall is due to a decrease in onboard dilution recovery when the diluent has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems.
The affected product is distributed worldwide, including the United States, Canada, and numerous other countries. Specific lot numbers and expiration dates are listed in the recall documentation, covering 2-pack and 6-pack configurations.
Healthcare facilities and users of the ADVIA Centaur and ADVIA Centaur XP systems should stop using the affected lots of Multi-Diluent 1 and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
Distribution
Distributed nationwide across the United States.
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