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

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.

Details from the source

Reason for recall: 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. Distribution: US States: FL, NY Quantity: 23 units Lot/code info: UDI-DI: (01)08718858480241 Lot Number: 00088454

UPC codes

08718858480241

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.