Kreatech PapV-16 — Class II medical device recall Z-0522-2025
Ongoing recall by Kreatech Biotechnology Bv, reported 2024-12-04, distributed in FL, NY. The DNA fragments for this specific lot number are too large, resulting in potential background around the cel
| Recall number | Z-0522-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kreatech Biotechnology Bv, Amsterdam, Netherlands |
| Recall initiated | 2024-11-01 |
| Classified | 2024-11-22 |
| Reported by FDA | 2024-12-04 |
| Distributed | FL, NY |
| Quantity | 23 units |
| UPC / GTIN / UDI-DI | 08718858480241 |
| Lot numbers | 00088454 |
| Model numbers | 40V016V495 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0522-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.