Siemens Acute Care pBNP TestPak Recalled Due to Barcode Scanning Issues
Siemens Healthcare Diagnostics Inc is recalling 1,157 Acute Care pBNP TestPaks because their barcode labels may not scan on Stratus CS 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, and the hazard involves a functional defect (barcode scanning) that could lead to operational errors or mislabeling, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 1,157 units of the Siemens Acute Care pBNP TestPak, an in vitro diagnostic test used to measure N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. The recall is being conducted because the barcode labels on the Stratus CS Cartridge may not scan correctly on Stratus CS systems.
The affected product is identified by Catalog Number CPBNPM and SMN 10445086. The specific lot numbers involved in this recall are 215166002, 215194002, 215222002, and 215271002.
The product was distributed worldwide, including in the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East. Healthcare facilities and laboratories should stop using the affected TestPaks and contact Siemens Healthcare Diagnostics Inc for instructions on how to return or replace the product.
The recalled product
- Product
- Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 1,157
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 (4)
- Lot Numbers: 215166002
- 215194002
- 215222002
- 215271002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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