Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage:… — Class II medical device recall Z-0103-2014
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2013-11-06, distributed nationwide. RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently
| Recall number | Z-0103-2014 |
|---|---|
| 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 | 2012-09-17 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2015-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CH, CL, CN, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KE, KR, KW, LT, LU, LV, MY, NL, NO, NZ, PH, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, VE, VN, ZA |
| Quantity | 4,494 units |
Product
Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Reason for recall
RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
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-0103-2014. 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.