UniCel DxC Synchron Systems No Foam Reagent 의 안전성 경고

Safety alert

2016-07-07

2016-07-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160707a.html

Medical device safety alert: beckman coulter unicel dxc synchron systems no foam reagent medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxc synchron systems no foam reagent [reference number: b64130]. dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. the manufacturer has identified an incompatibility between no foam dxc reagent (b64130) and the dxc hydropneumatic parts associated with no foam delivery. over time, this incompatibility may lead to: breaks in no foam cap assembly (pn a84827) cracks in no foam waste collector (pn a60007/a64665) seepage outside no foam tubing (pn’s a10027, a10028 and a67123) according to the manufacturer, this incompatibility does not affect no foam’s ability to perform its function and there is no impact to patient results. cracks in the waste collector may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure. also, cracks in the no foam cap and seepage from the no foam tubing may lead to exposure to no foam. the manufacturer is replacing no foam dxc reagent (ref b64130) with ref 469110, a previous unicel dxc systems no foam formulation. a hardware modification to replace impacted hardware and no foam tubing will be scheduled after completion of the switch over to the replacement no foam ref 469110. users can continue to use no foam dxc ref b64130 until replacement is received and they will be contacted for system modification scheduling. 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 july 2016.