Z-3012-2018 Class I Terminated
FDA device recall Z-3012-2018 was initiated by Ventana Medical Systems Inc on Aug 2, 2018 and is designated Class I. Reason for recall: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. The recall status is terminated (terminated Nov 22, 2021). Affected quantity: 468 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2018
- Initiation Date
- Aug 2, 2018
- Termination Date
- Nov 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 468 units
Product Description
CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for Recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Distribution Pattern
worldwide
Code Information
Lot Numbers: Y13547, Y19158, UDI: 4015630970469
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3012-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026