FDA Medical Device Recalls (openFDA)
Ventana Medical Systems Inc: CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Recall number
- Z-3012-2018
- Recalling firm
- Ventana Medical Systems Inc
- Product
- CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2018-08-02
- Posted
- 2018-09-14
- Terminated
- 2021-11-22
- Reason
- Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
- Root cause
- Under Investigation by firm
- Action
- The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
- Quantity
- 468 units
- Distribution
- worldwide
- Lot, serial or model codes
- Lot Numbers: Y13547, Y19158, UDI: 4015630970469
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PRB
- Firm FEI
- 1000125183
- Firm city
- Oro Valley
- Firm state
- AZ
- Firm country
- not on file
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