RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500… — Class II medical device recall Z-2079-2014
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2014-07-30, distributed nationwide. RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca
| Recall number | Z-2079-2014 |
|---|---|
| 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 | 2014-05-23 |
| Classified | 2014-07-18 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2015-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IT, JP, KR, KW, LT, LU, LV, MX, MY, NL, NO, NZ, PE, PL, PT, QA, RO, RS, SA, SE, SG, SI, TR, TW |
| Quantity | 20,507 cartridges |
| Serial numbers | 2334500011 |
| Model numbers | 10491447, 10491448, 10491449, 10844813 |
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 Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813
Reason for recall
RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
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-2079-2014. 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.