HPV-16 Diagnostic Probe Recalled for Suboptimal DNA Hybridization
Kreatech PapV-16 HPV-16 diagnostic probes are recalled for suboptimal DNA hybridization due to oversized DNA fragments. This may cause false positives or false negatives if proper laboratory controls are not used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic device with potential for false positive or false negative results in HPV-16 detection. While no illnesses have been reported, the risk of diagnostic error—particularly false negatives in cancer-screening applications—represents a risk-of-harm scenario per the rubric.
Plain-English summary
Kreatech Biotechnology Bv is recalling one lot of the Kreatech PapV-16 Flu labeled in situ hybridization (ISH) probe, a diagnostic test used to detect the presence of HPV-16 DNA in human tissue samples. The affected lot number is 00088454, with 23 units distributed to Florida and New York.
The DNA fragments in this lot are too large, resulting in suboptimal hybridization during testing. This can cause two types of errors: background signal around cells that may be misinterpreted as a positive result (false positive), or an absence of signal that may be misinterpreted as a negative result (false negative).
These misinterpretations could occur if proper positive and negative laboratory controls are not included in the testing process. Laboratories using standard quality control procedures should detect these issues.
If you have received this lot, verify that your testing protocols include appropriate positive and negative controls. Contact Kreatech Biotechnology Bv for information about lot replacement.
The recalled product
- Product
- Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
- Manufacturer
- Kreatech Biotechnology Bv
- Hazard
- diagnostic-inaccuracy
- false-positive
- false-negative
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)08718858480241 Lot Number: 00088454
Distribution
Distributed in 2 states:
- FL
- NY
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