Reported Dec 4, 2024 · Ongoing
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number…
Kreatech Biotechnology Bv
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kreatech Biotechnology Bv · Vlierweg 20 · Amsterdam · N/A
Is this the product you have?
- Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
- Lot codes and dates
- UDI-DI(01)08718858480241
- Lot Number00088454
- Amount recalled
- 23 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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