Phadia Prime with software up to and including version 2.1.4 . An in vitro diagnostic device (IVD) With Phadia 250, Phadia 2500E/EE and Phadia 5000E/E+E running EliA tests 의 리콜

Recall

RC-2017-RN-01452-1

Class II

2017-12-04

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01452-1

Erroneous results may occur as a result of a software issue with all versions of the phadia prime software up to and including version 2.1.4 connected to the phadia 250, phadia 2500e/ee and phadia 5000e/e+e instruments when running elia tests under specific scenarios as described below.The issue will cause the software to disregard default dilution factors for rejected samples, when using the “ok to all” function for retesting of samples if the following criteria are met: 1. more than one assay result are rejected within the same method -and- 2.The rejected results are run with tests which have different default dilution factorsif the two above scenarios occur at the same time, all samples will be retested with the dilution factor based upon the first rejected sample and assay dilution factor.

Abacus ALS is advising customers that this issue will be corrected through a mandatory update of the Phadia Prime software. A representative from Abacus ALS will be in contact with users as soon as the update is available. A copy of the customer letter should be retained in a prominent position until the update has been completed.