PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00678-1

Class II

2017-05-26

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00678-1

Siemens has confirmed a negative bias of approximately -20% for results obtained with dimension vista cer flex reagent cartridge when calibrating cer with specific prot 1 cal lots. prot 1 controls for cer are similarly biased. a deviation in the value assignment of the affected calibrators and controls is leading to a lower result compared to correctly assigned calibrators. patient samples with a true ceruloplasmin value of up to +20% above the lower end of the reference interval may be incorrectly found below the reference interval.

Siemens has assigned correct values to those lots of calibrators and controls where sufficient material was available for a new value assignment. Siemens is providing users with the correct values for these lots and advising users that these lots can be used for determination of ceruloplasmin with the revised assigned values and acceptance ranges. Lots for which revised values have not been provided are not to be used for ceruloplasmin measurements. The customer letter is to be reviewed with the laboratory Medical Director.