Dimension Vista Systems LOCI Thyroid Stimulating Hormone. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00357-1

Class II

2015-04-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00357-1

Siemens healthcare diagnostics has determined that dimension vista loci thyroid stimulating hormone (tsh) lot 14237aa may produce results with a negative bias ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a flex well. the occurrence of this issue is low. quality control will detect the issue if it is run near the end of an affected well set. the potential for clinical impact as a result of this issue is limited to a delay in hypothyroidism investigations. when this issue occurs, it is likely the negatively biased tsh values will not correlate reciprocally with free or total thyroid hormone values. in cases of monitoring tsh suppression for thyroid cancer, the potential for clinical misinterpretation of a patient’s response to thyroid hormone replacement therapy exists.

Siemens is instructing customers to discontinue and discard remaining inventory of the affected lot as a result of this issue. A look back at the previously generated results using the affected lot is recommended provided the sample is within the specified storage conditions and time, and where a TSH value within or below the reference interval did not reciprocally correlate with free or total thyroid hormone values.