# FDA recall Z-0522-2025

> **Kreatech Biotechnology Bv** · Class II · device recall initiated 2024-11-01.

## Product

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

## 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

## Key facts

- **Recall number:** Z-0522-2025
- **Recalling firm:** Kreatech Biotechnology Bv
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-01
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amsterdam, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2025

## Citation

> AI Analytics. FDA recall Z-0522-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0522-2025. Source: US FDA. Licensed CC0.

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