ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00005-2

Class III

2016-01-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00005-2

Siemens has confirmed that the lots ending in 263 and above are not meeting the current high-dose hook effect expectation that patient samples with total psa levels as high as 10,000 ng/ml (µg/l) will assay greater than 100 ng/ml (µg/l) as indicated in the instructions for use (ifu).Based on siemens’ internal testing, samples with total psa concentrations between 4200 ng/ml (µg/l) and 8400 ng/ml (µg/l) do not assay >100 ng/ml (µg/l) but instead result in falsely depressed concentrations of approximately 50 ng/ml (µg/l) to 94 ng/ml (µg/l).The disease state would be clinically apparent in a patient with a psa level >4200 ng/ml (ìg/l). a review of previously generated results due to this issue is at the discretion of the laboratory.

The sponsor is advising users to review the customer letter. Customers can continue to use this product with the understanding that patient samples with total PSA levels between 4200 and 8400 ng/mL (µg/L) will result in falsely depressed results between 50 and 94 ng/mL (µg/L). Customers may opt to change their dilution point based on their patient population and individual laboratory needs.