Beckman Coulter Allegra X-5 Rotor Yoke Recalled for Defect
Beckman Coulter is recalling Allegra X-5 rotor yokes because a defect allows improper rotor seating, which could lead to rotor failure if buckets are loaded in an imbalanced configuration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential rotor failure) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Beckman Coulter Inc. is recalling the Allegra X-5 rotor yoke, identified by Catalog Numbers B30589 and B30590 (Instruments) and B30593 (Rotor). The product is intended for in vitro diagnostic use to separate components through relative centrifugal force, including human samples like blood and body fluids, as well as non-human samples and chemicals. A total of 62 units are affected, with 33 units distributed in the United States, including Puerto Rico. The remaining units were distributed worldwide to Australia, Canada, Colombia, Germany, Guatemala, the Netherlands, Singapore, Tunisia, and Spain.
The recall is due to a defective rotor yoke that allows improper rotor seating on the hub. This defect results in a possible rotor failure if the buckets are loaded in an imbalanced configuration. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Qualified personnel operating the Allegra X-5 centrifuge should stop using the affected rotor yokes immediately. Beckman Coulter Inc. is the recalling firm responsible for addressing this issue. Users should refer to the specific lot codes provided in the recall notice to identify affected units.
The recalled product
- 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 de
- Manufacturer
- Beckman Coulter Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- AFB13H005
- AFB13H008
- AFB13H012
- AFB13K002
- AFB13K005
- AFB13K008
- AFB13J002
- AFB13J003
- AFB13J004
- AFB13J005
- AFB13J007
- AFB15J001
- AFB15C010
- AFB13K009
- AFB14H001
- AFB15C008
- AFB15C003
- AFB15C005
- AFB15C004
- AFB15C006
Distribution
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