The Recall Desk
SevereFDA (Devices)·Z-2692-2016·Announced 2016-09-07

Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Due to Fire Risk

Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer because flammable liquids may contact electrical components, posing a fire hazard.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential fire hazard due to flammable liquids contacting electrical components, which meets the rubric criteria for 'Severe' (score 4) involving significant injury or property-damage reports or structural defects, even though no specific injuries are reported in the text.

Plain-English summary

Beckman Coulter Inc. is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System (Catalog No. 775222). The recall involves 759 units total, with 358 units distributed in the United States and the remainder distributed internationally to numerous countries including Australia, Canada, China, Germany, Japan, and the United Kingdom.

The recall is being conducted to reduce the potential for flammable liquids to come into contact with electrical components in the Stainer module. This condition could possibly cause a fire. The device is a fully automated slide preparation and staining device used in cellular analysis.

No specific instructions for consumers or end-users are provided in the source text. Users of the affected devices should contact Beckman Coulter Inc. for further information regarding the recall and corrective actions.

The recalled product

Product
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a who
Hazard

Distribution

Distributed nationwide across the United States.