Siemens Healthcare BNP Test Kit Recalled for Temperature Sensitivity
Siemens Healthcare is recalling BNP test kits because room temperature changes may affect assay results on ADVIA Centaur systems.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a potential for inaccurate results due to temperature sensitivity but does not report specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling BNP (8-type Natriuretic Peptide) test kits, including 100-test and 500-test kits, used for in vitro diagnostic testing on ADVIA Centaur and ADVIA Centaur XP systems. The recall is due to the fact that the operating range of these systems is 18°C to 30°C (64.4°F to 86.0°F), and changes in room temperature may increase or decrease assay results depending on the specific assay and system used.
The affected products are distributed worldwide, including nationwide in the United States and in numerous international countries. The recall applies to all lot codes. The test kits are intended for the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma to aid in the diagnosis and assessment of heart failure severity and to predict survival in patients with acute coronary syndromes.
Healthcare facilities and users of these test kits should stop using the affected products and contact Siemens Healthcare Diagnostics, Inc. for further instructions on returns or replacements.
The recalled product
- Product
- Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
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)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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