Siemens RAPIDPoint 500 Measurement Cartridge Lactate — Class II medical device recall Z-2815-2015
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2015-09-30, distributed nationwide. RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on bot
| Recall number | Z-2815-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2015-08-24 |
| Classified | 2015-09-23 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2016-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IT, LT, LU, LV, MY, NL, NO, NZ, PL, PT, PY, RO, SE, SG, SI, SK, TR, TW, ZA |
| Quantity | 982 cartridges |
| Serial numbers | 2517102517 |
| Model numbers | 10491447 |
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
Reason for recall
RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2815-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.