VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00420-1

Class I

2016-04-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00420-1

A vitros system software timing anomaly has been identified that could cause two different sample metering scenarios that may lead to erroneous results.Scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample.Scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) to be contaminated and diluted by sample a.There is the potential for false negative and false positive results which may lead to an inappropriate diagnosis and patient management leading to serious patient injury.

Ortho is providing users with interim instructions to follow to decrease the probability of the issues occurring, and can review the affected systems to determine if the errors have occurred. It is recommended to discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. Ortho will be providing users with a software update (software version 3.2.3) as a permanent correction. This can be automatically downloaded for systems connected to e-Connect or software kits provided for systems not connected to e-Connect. This action has been closed-out on 20/02/2017.