medical Class II Updated 2024-12-04

Kreatech Biotechnology Bv recalls Kreatech PapV-16, Flu labeled ISH probe, to detect presence

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: FL, NY
Lot/Code Info: UDI-DI: (01)08718858480241 Lot Number: 00088454
View official government recall

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