Recall of Access Free T3 Reagent Kit (used in the diagnosis and monitoring of patients with thyroid disorders). An in vitro diagnostic medical device (IVD)

Recall

RC-2016-RN-00818-1

Class II

2016-06-17

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00818-1

Beckman coulter has determined through customer feedback and internal testing that the access free t3 reagent lots demonstrate an upward shift in patient results. the preliminary results indicate this upward shift may be related to a june 2015 formulation design change that was introduced to improve the access free t3 open reagent pack stability. the upward shift in patient test results, therefore, is expected to be maintained for all future lots. patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the june 2015 design change. due to matrix differences, qc values may not demonstrate a shift.

Beckman Coulter is advising users to discontinue use of the affected product and either verify the current Free T3 references interval(s) are appropriate or adjust or establish new reference intervals(s). Use of the affected lots can be resumed once the reference intervals have been evaluated. A review of previously generated results and clinical notification is at the discretion of the Laboratory Director. This acrtion has been closed out on 16 June 2017.