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…

Recall date

November 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0522-2025

FDA classification

Class II

Brand / firm

Kreatech Biotechnology Bv

Sold / distributed

US States: FL, NY

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495