Z-0522-2025Class II

Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model...

Name: Z-0522-2025 Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model...
Creator: Kreatech Biotechnology Bv
Published: 2024-11-01
License: https://open.fda.gov/license/

Kreatech Biotechnology BV / initiated 2024-11-01 / Open, Classified

FDA source

Kreatech Biotechnology Bv began a recall of Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495 on 2024-11-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0522-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-01
Posted: 2024-11-22
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
Product code: MVU Reagents, Specific, Analyte
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 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: [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].
Quantity in commerce: 23 units
Distribution: US States: FL, NY
Product codes and lots: UDI-DI: (01)08718858480241 Lot Number: 00088454

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0522-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0522-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-22

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)