Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V
Summary
The FDA issued a Class II for Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA insert by Kreatech Biotechnology Bv. Reason: The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An a.
Details
Source
Device Recall
External ID
Z-0522-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Lot/Code Info: UDI-DI: (01)08718858480241 Lot Number: 00088454
Quantity Affected: 23 units
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.
Distribution
US States: FL, NY
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-01
Company
Amsterdam
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kreatech Biotechnology Bv) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kreatech Biotechnology Bv have FDA actions?
This is the only FDA action we have on record for Kreatech Biotechnology Bv in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0522-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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