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 | A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration. |
| Product | Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only. |
| Quantity | 62 units total (33 units in US) |
| Distribution | Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain |
| Initiated | 2016-02-05 |
| Classified | 2016-07-22 |
| Terminated | 2017-01-17 |
| Recall number | Z-2274-2016 |
| 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-2274-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74567/
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