FDA Medical Device Recalls (openFDA)
Kreatech Biotechnology Bv: Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
- Recall number
- Z-0522-2025
- Recalling firm
- Kreatech Biotechnology Bv
- Product
- Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
- Status
- Open, Classified
- Initiated
- 2024-11-01
- Posted
- 2024-11-22
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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: QA.Amsterdam@leicabiosystems.com. 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 QA.Amsterdam@leicabiosystems.com.
- Quantity
- 23 units
- Distribution
- US States: FL, NY
- Lot, serial or model codes
- UDI-DI: (01)08718858480241 Lot Number: 00088454
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 3003137205
- Firm city
- Amsterdam
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28