Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2274-2016

February 05, 2016

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 74567
Status
Terminated
Classification
Class II
Quantity
62 units total (33 units in US)
Official record key
device-enforcement:Z-2274-2016

Official wording

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.

Code information: 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

Distribution pattern: Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.