N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00452-1

Class III

2017-04-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00452-1

Siemens healthcare diagnostics has observed lower values for carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to former lots. cdt results in absolute concentrations are influenced by the patient’s total transferrin levels and therefore results are reported as ratio of cdt to total transferrin, called %cdt. as the transferrin determination with n antiserum to human transferrin is not affected, the lower cdt result leads to calculated %cdt values that show a negative bias of approximately 10 to 15% compared to former lots. this could result in a shift of weak positive patient samples into the reference range of 1.19 – 2.47 %cdt which was derived from a study population of healthy adults. it is not expected that samples from patients with chronic heavy alcohol consumption will be misclassified.

Siemens is advising users to discontinue use of and discard the affected lots. Replacement stock will be provided by Siemens. It is recommended that users review the customer letter with the laboratory Medical Director.