Recall Z-0522-2025— Kreatech Biotechnology Bv
Class II · Ongoing
Class II FDA medical device recall by Kreatech Biotechnology Bv, initiated 2024-11-01. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Kreatech Biotechnology Bv
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-01
- Firm location
- Amsterdam, Netherlands
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.