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U.S. Department of Health and Human Services

Class 2 Device Recall Kreatech FISH probes

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 Class 2 Device Recall Kreatech FISH probessee related information
Date Initiated by FirmNovember 01, 2024
Date PostedNovember 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0522-2025
Recall Event ID 95668
Product Classification Reagents, specific, analyte - Product Code MVU
ProductKreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Code Information UDI-DI: (01)08718858480241 Lot Number: 00088454
FEI Number 3003137205
Recalling Firm/
Manufacturer		 Kreatech Biotechnology Bv
Vlierweg 20
Amsterdam Netherlands
For Additional Information ContactMargaret Walczak
815-200-2717
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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 in Commerce23 units
DistributionUS States: FL, NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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