The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below, manufactured by Ortho-clinical Diagnostics Inc.

• Product code: 6802783 and 6802413
• Unique device ID: 10758750002979 and10758750002740

According to the manufacturer, 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.

The manufacturer 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. Besides, the manufacturer is providing users with a software update (and associated modification modules) as a permanent correction.

For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-00420-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 14 April 2016