Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 76 units |
| Distribution | Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands. |
| Initiated | 2013-06-03 |
| Classified | 2013-07-31 |
| Terminated | 2014-08-23 |
| Recall number | Z-1834-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter Inc. (Z-1834-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65440/
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