FDA Device recall Z-1961-2015
The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in a…
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in a… by Siemens Healthcare Diagnostics, citing D50 and D51 Diagnostic error codes are not functional.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1961-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-06 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Reason
D50 and D51 Diagnostic error codes are not functional.
Identifiers
| code_info | Siemens Material Number (SMN): 10321846, 10491394, 10339910 |
|---|
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-1961-2015%22
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