Siemens Recalls Dimension Vista Urinary Protein Reagent Cartridges
Siemens is recalling Dimension Vista Urinary/Cerebrospinal Fluid Protein reagent cartridges due to confirmed absorbance errors during calibration.
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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,395 units of Dimension Vista Urinary/Cerebrospinal Fluid Protein (UCFP) Flex Reagent Cartridges, specifically Lot 11349BB. The recall is being conducted because Siemens confirmed an increase in absorbance errors when calibrating these specific cartridges.
The affected product is an in vitro diagnostic test used for the quantitative measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System. The recall covers worldwide distribution, including nationwide distribution in the United States and the United Kingdom.
Users of the affected product should stop using the recalled cartridges and contact Siemens Healthcare Diagnostics, Inc. for further instructions or a replacement.
The recalled product
- Product
- Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 3,395
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 No. 11349BB
Distribution
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