Alerta De Seguridad para UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

Safety alert

2016-08-11

2016-08-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_201608011.html

Medical device safety alert: beckman coulter unicel dxh slidemaker stainer coulter cellular analysis system medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh slidemaker stainer coulter cellular analysis system [part number reference 775222; all software revisions]. the manufacturer has received and confirmed a report of a fire within the stainer module of a customer’s dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module’s methanol bath. users are being advised to discontinue use of the stainer module to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire. the manufacturer is investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions. the manufacturer is advising users to: immediately discontinue use of the stainer module; drain all liquids from the stainer module; follow the directions provided for placing the stainer module in extended shutdown and disabling the stainer.; and a manufacturer’s service representative will schedule a visit to modify the stainer module so that it remains disabled and cannot be used until further corrective action is implemented. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 august 2016.