Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration
Siemens Healthcare Diagnostics is recalling 961 BNP kits due to complaints of failed calibration. The kits are used for in vitro diagnostic testing of B-type Natriuretic Peptide.
What this means for you
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 961 units of the SIEMENS ADVIA Centaur CP Immunoassay System BNP kit. The affected products are identified by Lot numbers 38059172 and 39463172. 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 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 further instructions. No specific consumer action is required for the general public, as these are professional in vitro diagnostic devices.
The recalled product
- Product
- SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 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
- 961
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# 38059172 and 39463172
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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