Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems) 의 리콜

Recall

RC-2014-RN-00922-1

Class II

2014-08-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00922-1

Siemens healthcare diagnostics has confirmed that when whole blood samples are run from small sample container (ssc – ks860 smn 10472099)), hba1c values may exhibit a percent bias ranging from -8.2% to +6.5% compared to results from the primary container. the percent bias range is a percentage of the hba1c result; it is not % hba1c units.

Siemens Healthcare Diagnostics is advising customer not to use Small Sample Containers (SSC) when running whole blood samples with Dimension Vista HbA1c assay and to process HbA1c samples according to the Instructions For Use for Primary Tubes or Sample Cups i.e. samples should be mixed by inversion (gently invert the tube ten times) or in a rocker mixer to obtain uniform distribution of erythrocytes prior to testing. Users are also advised that the need for a look back at previously reported results should be discussed with the laboratories Medical Director.