FDA Device recall Z-0106-2014
Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro…
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro… by Siemens Healthcare Diagnostics, citing RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0106-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-17 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: 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 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb
Reason
RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample
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-0106-2014%22
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