ADVIA Centaur and ADVIA Centaur XP (An in vitro diagnostic medical device (IVD)) 의 리콜

Recall

RC-2014-RN-01116-1

Class II

2014-10-15

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01116-1

Siemens healthcare diagnostics has identified an issue that on some systems a slight cracking of the tubing (the tubing for the wash 1, acid, and base bottle reservoirs) at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. the cracking may result in a minor drip of fluid onto the reservoir and into the drip tray located underneath the reservoirs. the potential for minimal fluid leakage outside the system exists. the drip will cause the reservoir to empty faster than the system expects. once the acid and base fluids are depleted, the system detects it and will flag all subsequent results with a signal error flag, once the lack of acid/base solution is detected. when wash 1 fluid becomes low, the system will detect it and stop processing samples. in this case, a limited number of test results (up to 20 tests) processed prior to a signal error may be affected and not flagged.

Siemens is advising the customers to examine their system to see if there is any fluid in the reservoir drip tray. If fluid is present, the customer is advised to contact their Siemens Customer Care Center or local Siemens technical support representative to schedule a visit. Until a service engineer has inspected their system for this issue, Siemens recommends that the customers replace the bulk bottle for all fluids immediately when the yellow warning appears. This will help mitigate the possibility of improper fluid dispenses. Siemens service engineers will inspect the tubing on the next service visit and replace the tubing if necessary. This action has been closed-out on 11/08/2016.