Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias
Siemens is recalling 1,213 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that affects patient test results (negative sodium bias), representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 1,213 units of the RAPIDPoint 500 Measurement Cartridge Lactate (400 tests), Part Number 10491448. The recall covers cartridges with 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 is being issued 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 a point-of-care or laboratory environment 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 countries in Europe, Asia, Africa, and South America. Healthcare professionals should stop using the affected cartridges and contact Siemens Healthcare Diagnostics Inc for further instructions.
The recalled product
- Product
- Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 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
- 1,213
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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