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Kreatech Biotechnology Bv recalls Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V
Recalled December 4, 2024 · FDA recall Z-0522-2025 · Kreatech Biotechnology Bv
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. · FDA Class II
Units
23 units
Sold at
US States: FL, NY
Description
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
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Manufacturer(s)
Kreatech Biotechnology Bv
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →