FDA Device recall Z-2274-2016
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593
- FDA Device
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593 by Beckman Coulter, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2274-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-05 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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.
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.
Identifiers
| code_info | AFB13H005, AFB13H008, AFB13H012, AFB13K002, AFB13K005, AFB13K008, AFB13J002, AFB13J003, AFB13J004, AFB13J005, AFB13J007…AFB13H005, AFB13H008, AFB13H012, AFB13K002, AFB13K005, AFB13K008, AFB13J002, AFB13J003, AFB13J004, AFB13J005, AFB13J007, AFB15J001, AFB15C010, AFB13K009, AFB14H001, AFB15C008, AFB15C003, AFB15C005, AFB15C004, AFB15C006, AFB14H005, AFB14H003, AFB13K004, AFB13K006, AFB13K007, AFB13J008, AFB13K001, AFB13J006, AFB13J010, AFB13H013, AFB13H009, AFB13H003, AFB13H004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2274-2016%22
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