Retiro De Equipo (Recall) de Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD).

Recall

RC-2017-RN-00196-1

Class II

2017-02-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00196-1

Siemens healthcare diagnostics has confirmed that the immulite 2000/immulite 2000 xpi sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with specific reagent lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use. reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots affected can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. this issue does not impact the immulite/immulite1000 platforms.

Siemens is advising that reconstituted adjustor lots 124 and 125 are to be stored at 2-8°C or -20°C for up to 14 days, after which they must be discarded. Based on the recommended calibration interval, this allows two calibration events at day 1 and 14 after opening the SHBG reagent kit. Replacement product can be requested from Siemens if adjustors available in the laboratory are not sufficient to utilise the full reagent kit. The customer letter should be reviewed by the laboratory Medical Director and review of previously generated results is at the discretion of the laboratory.