Dear valued customers and users,
In order to improve and standardize the usage of our IVD products, we have modified our IVD product line.
The changes affect the following components of the IVD product line:
• Assay-Mix: For all IVD products, the IPC assay mix will be integrated into the pathogen assay mix. This means that it is no longer necessary to pipette two assay mixes into the master mix.
• IPC-target: All products receive the same volume of IPC target. The IPC target will no longer contain guanidinium thiocyanate and Triton X-100 in accordance with REACH guidelines, reducing the risk to users. The dilution of RNA and DNA IPC target is harmonized to a dilution step of 1:100 when the target is added directly to the reaction (without extraction).
• Positive control: The volume of the positive control is increased and the required pipetting volume of the positive control is harmonized within the product groups. This means that all RNA kits require 10 µl positive control/reaction and all DNA kits require 9 µl positive control/reaction.
Please note that automated processes may be affected by these changes! For products with 100 or more reactions, the volume of the tubes has changed from 0.5 ml to 2.0 ml.
All of these changes come into effect for those IVD kits manufactured after May 1st ,2023. Attached you find a list of all affected products.
Please be sure to read the latest version of the Instructions for Use (available on our website from May 2nd , 2023) and familiarize yourself with the changes before using a new kit. If you would like to receive a copy in advance, please contact us directly at firstname.lastname@example.org.
For any further questions regarding the changes, please do not hesitate to contact us by phone or email.