AU5800 Clinical Chemistry Analyzer with Automation Ready Connection — Class II medical device recall Z-1834-2013
Terminated recall by Beckman Coulter Inc., reported 2013-08-07, distributed nationwide. The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the
| Recall number | Z-1834-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-06-03 |
| Classified | 2013-07-31 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2014-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, GB, IL, IT, JP, NL, SG, TR |
| Quantity | 76 units |
| Reason classes | packaging, software |
| Model numbers | A91921, A91949, A94906, A94907, A94908, A94909, A94910, A94911, A94912, A94913, A94914, A94915, A94916, A94917, A94918, A94920, A94922, A94923, A94924, A94925, AU5811, AU5811-01, AU5811-02, AU5811-03, AU5811-04 and 19 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1834-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.