RAPIDPoint 405 Blood Gas Analyzer — Class II medical device recall Z-1252-2015
Terminated recall by Siemens Healthcare Diagnostics Inc, reported 2015-03-18, distributed nationwide. Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater th
| Recall number | Z-1252-2015 |
|---|---|
| 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 | 2014-12-30 |
| Classified | 2015-03-06 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2017-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BG, BH, BR, CA, CH, CL, CO, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HR, HU, IE, IL, IQ, IS, IT, KW, LB, LT, LU, LV, MX, NL, NO, PE, PL, PT, QA, RO, RS, RU, SA, SE, SI, SK, TR, VE, ZA |
| Quantity | 3,420 devices |
Product
RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. 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: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.
Reason for recall
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.
Machine access
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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.