Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2016-RN-01555-1

Class II

2016-11-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01555-1

Siemens has confirmed that immulite 2000 / immulite 2000 xpi intact pth kit lot 320 can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg/ml (<2.1 pmol/l) with serum and edta patient samples vs. a reference kit lot. for ipth concentrations of 20 to <50 pg/ml (2.1 to <5.3 pmol/l) the average bias was - 22%, for 50 to <100 pg.Ml (5.3 to <10.5 pmol/l) it was -18% and for =100 pg/ml ( =10.5 pmol/l) it was -5%. depending upon the quality control ranges used by your laboratory, this issue may not be detected by quality controls. when this issue occurs, the potential exists for misinterpretation of ipth levels which may delay determination of the etiology of hypercalcemia or hypocalcemia. clinical impact would be mitigated by correlation to clinical symptomology and additional diagnostic laboratory testing.

Users are advised to discontinue use of and discard Immulite 2000/Immulite 2000 XPi Intact PTH kit lot 320. Affected product will be replaced by Siemens. The review of previously generated results is at the discretion of the laboratory.