Kreatech Biotechnology Bv has recalled 23 units of its Kreatech PapV-16 Flu labeled ISH probes, model number 40V016V495. This recall was initiated because the DNA fragments in a specific lot are too large, which can cause the test to perform suboptimally. This defect may lead to incorrect test outcomes, including false positives or false negatives for HPV-16 DNA. There have been no reports of incidents or injuries related to this issue.
The larger DNA fragments can cause background interference or a lack of signal during testing. If laboratory controls are not properly monitored, this can result in a false positive, where the virus is incorrectly identified, or a false negative, where an actual infection is missed.
Used to detect presence of HPV-16 DNA inserts in human tissue.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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