Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers:… — Class III medical device recall Z-2913-2016
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2016-10-12, distributed nationwide. Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measuremen
| Recall number | Z-2913-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics Inc, Norwood, MA, United States |
| Recall initiated | 2016-09-02 |
| Classified | 2016-09-30 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-08-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BS, CA, CN, CZ, DE, ES, FR, IT, JP, KR, MX, PL |
| Quantity | 6,638 cartridges |
| Serial numbers | 2610900214 |
| Expiration dates | 2016-09-13 |
Product
Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
Reason for recall
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
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-2913-2016. 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.