N Latex ß2–Microglobulin 의 리콜

Recall

RC-2015-RN-01054-1

Class II

2015-11-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01054-1

Siemens healthcare diagnostics has received complaints from customers not being able to establish a calibration curve or to validate an established calibration curve with the respective controls when using one of the affected lots of n latex ß2-microglobulin. the issue might lead to the inability to calibrate the assay or to obtain invalid test runs. however, patient results are not affected. there is the potential for the user to be exposed to assay components contaminated with pseudomonas libanensis, pseudomonas rhodesiae and pseudomonas extremorientalis. exposure may lead to an infection and its consequencesa review of previously generated results due to this issue is at the discretion of the laboratory.Siemens advises that the delay of results for these assays does not represent a hazard, and as a result the severity level is none or negligible.

Customers are asked to discontinue use of and discard the affected lots listed in the Customer Letter. A replacement or credit will be issued as per the normal procedure.