Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration
Siemens is recalling 1,191 BNP immunoassay kits worldwide due to complaints of failed calibration. The kits are used for in vitro diagnostic testing.
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. The hazard is a functional defect (failed calibration) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,191 units of the SIEMENS ADVIA Centaur CP Immunoassay System BNP kit, SMN 10309044. The affected lots are 38479172 and 39181172. These kits are used for in vitro diagnostic purposes to quantitatively determine B-type Natriuretic Peptide (BNP) in human plasma.
The recall was initiated due to complaints of failed calibration. The affected products were distributed worldwide, including the United States (nationwide including Puerto Rico) and numerous international locations such as Canada, Australia, and various countries in Europe, Asia, and the Middle East.
Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for instructions on return or replacement. No specific consumer action is required for the general public, as these are professional in vitro diagnostic products.
The recalled product
- Product
- SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 1,191
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)
- Lot# 38479172 and 39181172
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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