Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Kreatech PapV-16 Recalled by Kreatech Biotechnology Bv Due to The DNA fragments for this specific lot number...

Date: November 1, 2024
Company: Kreatech Biotechnology Bv
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Kreatech Biotechnology Bv directly.

Affected Products

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

Quantity: 23 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 2 states: FL, NY

Affected (2 states)Not affected

About Kreatech Biotechnology Bv

Kreatech Biotechnology Bv has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report