Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Recall
- Recall Number
- Z-0522-2025
- Event Number
- 95668
- Firm
- Kreatech Biotechnology Bv Vlierweg 20 Amsterdam Netherlands
- FEI Number
- 3003137205
- Product Code
- MVU
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 1, 2024
- Posted
- November 22, 2024
Description
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.
An URGENT MEDICAL DEVICE RECALL notification letter dated 10/31/24 was sent to customers. Actions to Be Taken by the Customer/User 1. Do not use or continue to use the batch listed above. You will receive a replacement product as soon as possible. 2. Please dispose of any unused products according to your organization s disposal policies. 3. Review and follow up on any results obtained using the above-mentioned product batch. 4. Please read and retain this communication. Please confirm receipt of this letter as soon as possible by signing and returning the below Acknowledgement Form to: [email protected]. Transmission of This Notification Letter Kindly please pass this notification to the users of this product and to all those within your organization who need to be aware of this issue. If you have any questions about this notification letter, please contact your local Leica Biosystems representative or contact [email protected].
US States: FL, NY
23 units