Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes
Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Lactate Cartridges because they may display error codes for electrolyte parameters.
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 is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible health consequences. The hazard involves potential diagnostic errors regarding electrolyte parameters, which is a significant risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling the RAPIDPoint 500 Measurement Cartridge Lactate in various pack sizes (100, 250, 400, and 750 tests). The recall involves 20,507 cartridges with serial numbers ranging from 2334500011 through 2412705915. These products were distributed nationwide and in numerous foreign countries.
The recall was initiated because the RAPIDPoint 500 Measurement Cartridges may have an error code for one or more electrolyte parameters, such as sodium (Na+), calcium (Ca++), potassium (K+), or chloride (Cl-). This issue is classified as an FDA Class II recall.
Healthcare facilities and consumers should stop using the affected cartridges and contact Siemens Healthcare Diagnostics Inc for further instructions or a replacement.
The recalled product
- Product
- RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 20,507
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)
- Serial Numbers: 2334500011 through 2412705915
Distribution
Distributed nationwide across the United States.
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