RAPIDLab 1245 System — Class II medical device recall Z-1254-2015
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-1254-2015 |
|---|---|
| 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 | 241 devices |
Product
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
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.