FDA Device recall Z-1834-2013
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841
- FDA Device
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841 by Beckman Coulter, citing the recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1834-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-03 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
Reason
The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. This software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
Identifiers
| code_info | Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU…Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Serial Numbers: All |
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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-1834-2013%22
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