Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Published December 4, 2024 · Recall initiated: November 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kreatech Biotechnology Bv
- Distributor
- US States: FL, NY
- Lot
- UDI-DI: (01)08718858480241 Lot Number: 00088454
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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