FDA Device recall Z-0522-2025
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495 by Kreatech Biotechnology Bv, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0522-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-01 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Kreatech Biotechnology Bv |
| Distribution | FL, NY |
Product
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Reason
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.
Identifiers
| code_info | UDI-DI: (01)08718858480241 Lot Number: 00088454 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0522-2025%22
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