The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has posted a medical device safety alert concerning ORTHO VISION Analyzer and ORTHO VISION Max Analyzer, manufactured by Ortho Clinical Diagnostics.

The affected devices are identified as follows:-

• A) ORTHO VISION Analyzer for ORTHO BioVue Cassettes; B) ORTHO VISION Max Analyzer for ORTHO BioVue Cassettes
• Product code: A) 6904579 and B) 6904578
• Software Version: 3.6.0 and Below

The manufacturer confirmed that if incubation time parameters are changed when creating a User Defined Protocol (UDP) test, then the incubation time of the Ortho test template and other UDP tests created from the same test template may change. The system will update the incubation time with the latest selection for all UDPs that use the same template, and will also update the Ortho test template, as described in the example below:

• UDP Test 1 is defined with the Ortho test 08 ABScr Surg Poly, and the minimum incubation time parameter is set at the default time of 15 minutes.
• An additional UDP, UDP Test 2, is subsequently defined with the same Ortho test 08 ABScr Surg Poly, and the minimum incubation time is set to 30 minutes.
• The minimum incubation time for UDP Test 1 and the template test Ortho test 08 ABScr Surg Poly is unexpectedly changed by the system software to the default time of 30 minutes (i.e., the minimum incubation time parameter of UPD Test 2). The user is not notified of the change.

The incubation time parameters will reset back to the values from the Assay Data Disk (ADD) for the Ortho test template and the associated UDPs will be reset to the original validated parameters during restart of the analyzer.

The unintentional change to the UDP assay incubation time parameter on the Ortho VISION and VISION Max Analyzer may cause over- or under-incubation for tests, potentially leading to false positive or false negative test results. The affected UDP assays may include antibody screening and identification tests, DAT, antigen typing, as well as Ortho Sera (IgG) or other Antisera tests.

Affected users are instructed to take the following action:-

• After adjusting the incubation time parameters of a UDP test, make sure to restart the system prior to processing samples so that the incubation time parameters will reset back to the values from the Assay Data Disk (ADD) for the Ortho test template and the associated UDPs will be reset to the original validated parameters during restart of the analyzer.

This issue will be addressed in software version 4.8.0 (MOD 16) that is targeted to be released by year end 2016.

According to the local supplier, the affected products are distributed in Hong Kong.

For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-28-november-2-december-2016

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

Posted on 6 December 2016