Beckman Power Express Centrifuge Sample Holder May Detach During Operation
An adhesive joint failure in the PE Centrifuge Temperature Controlled component can cause the metal part to detach inside the centrifuge, risking sample destruction and potential exposure of laboratory technicians to biohazardous material.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm medical device with potential for biohazard exposure and sample destruction, but no reported injuries or illnesses to date. This meets the criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Biomedical GmbH is recalling the PE Centrifuge Temperature Controlled (REF: B36366), a component of the Power Express laboratory centrifuge system. This device is distributed worldwide, including throughout the United States and 22 additional countries.
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail. When failure occurs, the metal part may detach and enter the centrifuge during operation. This failure can result in damage to the centrifuge, destruction of patient samples causing delayed results, and potential exposure of laboratory technicians to biohazardous material.
Healthcare facilities and laboratories using the Power Express centrifuge system with this component are affected. The recall applies to all serial numbers of the affected component (UDI: (01)15099590673567).
Laboratory staff should immediately discontinue use of the affected PE Centrifuge component and contact Beckman Coulter Biomedical GmbH for replacement instructions and guidance.
The recalled product
- Product
- PE Centrifuge Temperature Controlled, REF: B36366, 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)15099590673567/ All serial numbers
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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