FDA Enforcement
Class II
Ongoing
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Recall: Z-0522-2025
·
Reported December 4, 2024
Enforcement
- Recall Number
- Z-0522-2025
- Event ID
- 95668
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Kreatech Biotechnology Bv
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2024
- Initiation Date
- November 1, 2024
- Classification Date
- November 22, 2024
- Address
- Vlierweg 20, Amsterdam, N/A, Netherlands
Description
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Reason
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.
Code Info
UDI-DI: (01)08718858480241 Lot Number: 00088454
Distribution
US States: FL, NY
Quantity
23 units