Kreatech Biotechnology Bv: Medical Device Recall in 2024 - (Recall #: Z-0522-2025)
See the recall detail below. You can also see other recalls from the same firm in 2024.
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Class II
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.
UDI-DI: (01)08718858480241 Lot Number: 00088454
US States: FL, NY
Voluntary: Firm initiated
