Power Express PE Centrifuge adhesive joint failure may cause component detachment
The adhesive joint in this medical device component can fail, causing the metal part to detach. This may damage the centrifuge, destroy patient samples, and potentially expose lab staff to biohazardous material.
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: FDA Class II recall with no reported illnesses or injuries. This is a risk-of-harm product where injury has not yet been reported, fitting the Score 3 criterion per the rubric.
Plain-English summary
Beckman Coulter Biomedical GmbH is recalling the PE Centrifuge, model REF: B36365, a component of the Power Express Sample Holder. The device is used in laboratories for sample processing.
The adhesive joint connecting the plastic socket to the metal component can fail. When this occurs, the metal part may detach and fall into the centrifuge, potentially damaging the equipment and destroying patient samples.
This defect may result in delayed test results and damage to the centrifuge. Lab technicians may also be exposed to biohazardous material during operation or cleanup if a sample is destroyed.
The product has been distributed worldwide, including throughout the United States and to additional countries. Users who have this device should contact Beckman Coulter Biomedical GmbH or the FDA for guidance.
The recalled product
- Product
- PE Centrifuge, REF: B36365, a component of the Power Express
- Manufacturer
- Beckman Coulter Biomedical GmbH
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 (1)
- UDI: (01)15099590673550/ All serial numbers Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Beckman Coulter Biomedical GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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