Siemens ADVIA Centaur BNP Assay Recalled for Potential Analyzer Malfunction
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP assays because they may cause analyzer malfunction or reduced dilution recovery when used with specific diluents.
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, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a functional device defect (analyzer malfunction) rather than a direct patient safety risk, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur BNP (B-type Natriuretic Peptide) assays, catalog numbers 02816138 and 02816634. The recall affects 21,687 units with lot numbers ending in 192, 193, or 196. These products were distributed in 28 U.S. states, Puerto Rico, and numerous countries outside the United States.
The recall was initiated because the assays may exhibit reduced dilution recovery or cause the ADVIA Centaur CP, XP, and XPT immunoassay analyzers to become inoperable when used with Multi-Diluent 15. This issue is specific to the interaction between the recalled BNP assay lots and the specified diluent.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 21,687
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)
- Lot Numbers ending in: 192
- 193
- 196
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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