UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems 의 안전성 경고

Safety alert

2016-08-17

2016-08-17

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_201608017.html

Medical device safety alert: beckman coulter unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh 800 and unicel dxh 600 coulter cellular analysis systems. the affected products are identified as follows: unicel dxh 800 coulter cellular analysis system reference.: 629029, b24465, b24802, b68304 software version: all unicel dxh 600 coulter cellular analysis system reference: b23858 software version: all maccording to the manufacturer, there is a possibility of specimen misidentification for the stand-alone dxh 800 and dxh 600 where the primary identifier is configured to tube position id. this issue does not occur if the primary identifier is configured as specimen id mresults from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs: the primary identifier is tube position id. a patient control file is setup for id xxxxx, and a pending test order for a patient sample id xxxxx is subsequently added to the worklist. the patient control sample is analyzed using cassette presentation but that tube does not contain a barcode-labeled specimen id or the label cannot be read. mupon analysis, the results from the analyzed patient control tube will be associated with the patient sample that was pending on the worklist and not the patient control file mthe manufacturer is investigating this issue in order to provide a resolution. affected users are advised to ensure that there are no pending or active patient test orders in the worklist before analyzing a patient control with a tube position id maccording to the local supplier, unicel dxh 800 coulter cellular analysis system is distributed in hong kong mif you are in possession of the affected products, please contact your supplier for necessary actions. mposted on 17 august 2016.