Z-0522-2025 Class II Ongoing
FDA device recall Z-0522-2025 was initiated by Kreatech Biotechnology Bv on November 1, 2024 and is designated Class II. 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 resul… The recall status is ongoing. Affected quantity: 23 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- November 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 units
Product Description
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
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.
Distribution Pattern
US States: FL, NY
Code Information
UDI-DI: (01)08718858480241 Lot Number: 00088454