N Latex CDT. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2018-RN-00645-1

Class II

2018-06-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00645-1

Siemens healthcare diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to the hplc method.Cdt results in absolute concentrations may be influenced by patient’s 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 observed effect leads to calculated %cdt values that show a negative bias of approximately 15% compared to the hplc method. 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.

Siemens Healthcare Diagnostics has assigned optimised values to the affected lots of standards and controls included in the kit lots. Those lots of standards and controls can be used with the revised assigned values and acceptance ranges. Siemens is advising users to: · Recalibrate their CDT method with N CDT Standard lots listed in the Customer Letter, using the revised assigned values provided in the communication. · Use the revised assigned values and respective ranges of the N CDT Controls provided in the Customer Letter. · For BN ProSpec and Atellica NEPH 630 customers, a new Lot Data CD as well as new Secure Download Files are expected to be available in June 2018 including the revised CDT target values for N CDT Standard, N CDT Control 1 and N CDT Control 2. · Ensure that the values manually entered according to the Customer Letter are not overwritten by using an older Lota Data CD/Secure Download File afterwards.