FDANovember 1, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Ongoing

Brands named

kreatech biotechnology bvkreatechkreatech biotechnology

UPCs

08718858480241

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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