Kreatech PapV-16 ISH Probe (Kreatech) – DNA fragment size issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Brand
Kreatech Biotechnology Bv Vlierweg 20 Amsterdam Netherlands
Lot Codes / Batch Numbers
UDI-DI: (01)08718858480241 Lot Number: 00088454
Products Sold
UDI-DI: (01)08718858480241 Lot Number: 00088454
Kreatech Biotechnology Bv Vlierweg 20 Amsterdam Netherlands is recalling Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, M due to The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, NY
Page updated: Jan 10, 2026