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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00209-1
Product Name/Description 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)

VITROS Total B-hCG II Reagent Packs
Unique Device ID: 10758750002320, 20758750002327
Product Code: 6802220

VITROS Total B-hCG II Calibrators
Unique Device ID: 10758750002337, 20758750002334
Product Code: 6802221

Lot Number: 1420

Expiry date: 17/06/2016

ARTG Number: 176641
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/02/2016
Responsible Entity Ortho-Clinical Diagnostics
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.

This action has been closed out on 29/10/2018
Contact Information 1800 032 359 - Ortho Clinical Customer Technical Services