Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias
Siemens is recalling 49 RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.
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 3/5 (High).
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 results (negative sodium bias), representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 49 units of the RAPIDPoint 500 Measurement Cartridge Lactate (100 tests), Part Number 10844813. 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 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. 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 (100) tests Part Number: 10844813 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…
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 49
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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