Unicel DxH Cellular Analysis Systems 의 안전성 경고

Safety alert

2015-12-07

2015-12-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151207b.html

Medical device safety alert: beckman coulter unicel dxh cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning unicel dxh 800, dxh slidemaker stainer (sms) and dxh 600 cellular analysis systems. the affected products are identified as follows: dxh 800: reference number: 629029, b24465, b24802; software version: 3.0.2.0 dxh sms: reference number: 775222; software version: 3.0.2.0 dxh 600: reference number: b23858; software version: 1.1.1.0 the manufacturer has determined that the software for the affected dxh systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager. the issue does not occur for edits of released results or for test orders requested through host transmission. according to the manufacturer, the issue creates the potential for sample misidentification and possibility of releasing erroneous results. the manufacturer is advising customers not to edit the specimen id for a pending test order at the system manager’s worklist – pending or worklist – review tabs. 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 7 december 2015.