Recall of VITROS Immunodiagnostic Products Total B-hCG II Reagent Packs & Calibrators (used with ECi/ECiQ, 3600 Immunodiagnostic Systems and 5600 Integrated Systems). An in vitro diagnostic medical device (IVD)

Recall

RC-2016-RN-00209-1

Class II

2016-02-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00209-1

Ortho clinical diagnostics (ortho) got reports that their vitros system reported results up to approximately 7.40 miu/ml (iu/l) for patient plasma samples that should have been less than the measuring range of the assay (<2.39 miu/ml (iu/l)). ortho’s investigation identified that results generated using plasma samples were positively biased compared to those using serum samples for the same patient. data indicates that samples expected to be less than the measuring range (<2.39 miu/ml (iu/l)) may potentially be reported as high as 7.72 miu/ml (iu/l). a low false positive hcg result, indicating a suspected very early pregnancy, may cause a delay of a therapeutic procedure or a diagnostic imaging procedure involving radiation, which may potentially lead to the delay of diagnosis and patient management.

Ortho is advising users to discontinue use and discard all remaining inventory of the affected reagent packs and calibrators. Affected stock will be replaced with unaffected product. Ortho is recommending a review of previously reported hCG results of <9.00mIU/mL(IU/L) for plasma samples processed using the affected lots and discuss any concerns with the Laboratory Medical Director.