Medical Device Sample Holder Recalled for Adhesive Joint Failure
Beckman Coulter Power Express sample holders can fail at the adhesive joint between plastic socket and metal component. This may cause the metal part to detach inside the centrifuge, potentially damaging equipment and exposing 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: This is an FDA Class II recall for a medical device with a structural failure risk. No illnesses or injuries have been reported, but the hazard involves potential exposure to biohazardous material and equipment damage, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Beckman Coulter Biomedical GmbH is recalling the Power Express Sample Holder (REF B90918) due to a failure risk in the adhesive joint that connects the plastic socket to the metal component.
The adhesive joint can fail, causing the metal part to detach. If detachment occurs during centrifuge operation, the metal component can enter the centrifuge. This may result in damage to the centrifuge equipment, destruction of the patient sample, delayed laboratory results, and potential exposure of laboratory technicians to biohazardous material.
The recall affects all serial numbers of Power Express sample holders distributed worldwide, including the United States.
For more information, affected users should contact the manufacturer or refer to FDA recall number Z-2978-2024.
The recalled product
- Product
- Power Express, REF B90918
- Manufacturer
- Beckman Coulter Biomedical GmbH
- Hazard
- structural-failure
- detachment-hazard
- biohazard-exposure
- equipment-damage
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)15099590681555/ All serial numbers
Distribution
Distributed nationwide across the United States.
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