Iron Assay performed with the Dimension & Dimension Vista Systems. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01186-1

Class II

2016-09-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01186-1

Siemens healthcare diagnostics has become aware of deferoxamine interference with dimension and dimension vista iron assays at a different concentration than listed in the instructions for use (ifu). deferoxamine is listed in the dimension and dimension vista ifu’s as a non-interfering substance. the concentration that was used for interference testing (3.8 nmol/l) is significantly below what would be expected in clinical practice. siemens healthcare diagnostics is providing an update to the limitation of procedure section for the dimension and dimension vista iron assays instructions for use (ifu) to indicate that: patients treated with metal-binding drugs (e.G. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay.The reference to deferoxamine at a concentration of 3.8 nmol/l will be removed from the non interfering substances section of the ifu.

Siemens is advising users that the Limitation of Procedure section of the Instructions for Use (IFU) will be updated to include "patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay". This information supersedes the current IFU while the IFU is being updated. Siemens is not recommending a review of previous results however a review is at the discretion of the laboratory director.