Kreatech PapV-16, Flu labeled ISH probe, to detect presence… recallZ-0522-2025 · Kreatech Biotechnology Bv · initiated Nov 1, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Kreatech Biotechnology Bv or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT MEDICAL DEVICE RECALL notification letter dated 10/31/24 was sent to customers. Actions to Be Taken by the Customer/User 1. Do not use or continue to use the batch listed above. You will receive a replacement product as soon as possible. 2. Please dispose of any unused products according to your organization s disposal policies. 3. Review and follow up on any results obtained using the above-mentioned product batch. 4. Please read and retain this communication. Please confirm receipt of this letter as soon as possible by signing and returning the below Acknowledgement Form to: [email protected]. Transmission of This Notification Letter Kindly please pass this notification to the users of this product and to all those within your organization who need to be aware of this issue. If you have any questions about this notification letter, please contact your local Leica Biosystems representative or contact [email protected].
Recall details
- Recall number
- Z-0522-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 1, 2024
- Posted by the FDA
- Nov 22, 2024
- Recalling firm
- Kreatech Biotechnology Bv
- Quantity
- 23 units
- Product code
- MVU
- Distribution
- US States: FL, NY
Product description
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Code information (models, lots, serial numbers)
UDI-DI: (01)08718858480241 Lot Number: 00088454
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Kreatech FISH probes 40V016V495Leica Biosystems Newcastle Ltd · Reagents, specific, analyte1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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