Kreatech Biotechnology Bv: Device Recall
Recall #Z-0522-2025 · 11/01/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0522-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Kreatech Biotechnology Bv
- Status
- Ongoing
- Date Initiated
- 11/01/2024
- Location
- Amsterdam, Netherlands
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
Reason for Recall
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.
Product Description
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Distribution Pattern
US States: FL, NY
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.