Siemens Healthcare Diagnostics Inc: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Agency Publication Date: September 24, 2015

Affected Products

Product: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 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 hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

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

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 hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

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

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 hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

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

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 hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCHb, FMetHb, FHHb, nBili

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72044

Status: Resolved

Manufacturer: Siemens Healthcare Diagnostics Inc

Manufactured In: United States

Units Affected: 4 products (2079 cartridges; 1213 cartridges; 982 cartridges; 49 cartridges)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

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