CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
Kreatech PapV-16, Flu labeled ISH probe recalled
Kreatech Biotechnology is recalling Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in, distributed in Florida, New York. The recall was initiated on 1 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0522-2025
- FDA event ID
- 95668
- Recalling firm
- Kreatech Biotechnology, Amsterdam
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2024
- FDA classified
- 22 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Nov 2024 | Recall initiated by company | |
| 22 Nov 2024 | Classified by FDA | +21 days |
| 4 Dec 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Where it was distributed
US States: FL, NY
Questions about this recall
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.
Which lots are affected?
UDI-DI: (01)08718858480241 Lot Number: 00088454
Where was it sold?
US States: FL, NY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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