FDA Device recall Z-1252-2015
RAPIDPoint 405 Blood Gas Analyzer
- FDA Device
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of RAPIDPoint 405 Blood Gas Analyzer by Siemens Healthcare Diagnostics, citing 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 ra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1252-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-30 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
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.
Identifiers
| code_info | All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1252-2015%22
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