FDA Medical devices recall ·
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA… recall
- Recall number
- Z-0522-2025
- Date
- (initiated November 1, 2024)
- Company / brand
- Kreatech Biotechnology Bv
Vlierweg 20, Amsterdam, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 23 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: (01)08718858480241 Lot Number: 00088454
Distribution
US States: FL, NY
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0522-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.