FDA Device recall Z-1255-2015
RAPIDLab 1265 System
- FDA Device
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of RAPIDLab 1265 System 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-1255-2015 |
| 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
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. 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
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-1255-2015%22
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