Agency classClass IIOur severity:High FDA (Devices)·Z-2978-2024·Announced 2024-09-11

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.

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: 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
Category: Medical Device — Laboratory Equipment
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.

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.

See all 3 products in this recall →

Same manufacturer · Beckman Coulter Biomedical GmbH

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Same hazard · structural failure