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 | Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak. |
| Product | AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood. |
| Quantity | 108 units |
| Distribution | Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP. |
| Initiated | 2013-04-26 |
| Classified | 2013-05-29 |
| Terminated | 2014-08-04 |
| Recall number | Z-1430-2013 |
| 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-1430-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65118/
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