Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias
Siemens is recalling 982 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.
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, 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 982 units of the RAPIDPoint 500 Measurement Cartridge Lactate (250 tests), Part Number 10491447. The recall covers serial numbers 2517102517 through 2519000012. Cartridges within this serial number range that have a green dot on the box and/or the cartridge are not affected.
The recall was initiated because the affected cartridges exhibit a negative sodium bias on both quality control and patient results. The RAPIDPoint 500 system is designed for professional use in point-of-care or laboratory environments to test blood gases, electrolytes, metabolites, and hemoglobin derivatives in whole blood samples.
The affected products were distributed worldwide, including the United States, Canada, and numerous other countries. Users should check their inventory for the specific serial numbers and part number listed above. If the product matches the description and does not have the green dot indicator, it should be removed from use.
The recalled product
- Product
- Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemo
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 982
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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