Dear valued customers and users,
we would like to inform you about the upcoming change of some products.
The change will come into effect gradually from September 1, 2023.
The following products are affected by this change:
| Product | Reactions | Orderno. |
| FetoGnost® Kit RHD | 100 | HUFG100 |
| FetoGnost® Kit RHD | 500 | HUFG500 |
| FetoGnost® Kit Control | 50 | HUFG050 |
Attention: During the transition period, both product versions may be in circulation. However, the new product versions will be marked with clearly visible information folders.
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The product FetoGnost® Kit RHD (order numbers: HUFG100; HUFG500) has received the following changes:
- The buffer within the component “FetoGnost® Kit IPC Target” does no longer contain any dangerous substances. The Target-concentration was slightly increased, the expected CT-value range in the interpretation of data (see IFU, point 11.1) was adjusted.
- The volume of the component “FetoGnost® Kit IPC Target” has been increased from 200 µl to 300 µl.
- The volume of the component “FetoGnost® Kit RHD Positive Control” (HUFG100) has been increased from 100 µl to 300 µl.
- The volume of the component “FetoGnost® Kit RHD Positive Control” (HUFG500) has been increased from 500 µl to 1.000 µl.
The general workflow for using the product remains unchanged by these changes. However, mixing product versions 1.0 and 1.1 in the same experiment is not recommended.
The new product version is 1.1. The version of the revised IFU is 2.0. Please read it carefully before use!
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The product “FetoGnost® Kit Control (order number: HUFG050)” has received the following changes: Please read through these before use!
- The screw cap of the component “FetoGnost® Kit Control Restriction Buffer” is now transparent instead of blue.
- The screw cap of the component “FetoGnost® Kit Control Restriction Enzyme” is now dark brown instead of blue.
- The volume of the component “FetoGnost® Kit Control Positive Control” has been increased from 200 µl to 300 µl.
The general workflow for using the product remains unchanged by these changes. However, mixing product versions 1.1 and 1.2 in the same experiment is not recommended.
The new product version is 1.2. The version of the revised IFU is 1.2. Please read it carefully before use!
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If you have any questions about the changes, please feel free to email us at office@ingenetix.com or call +43 1 361 98 01.
Sincerely,
Your Ingenetix team