Z-3010-2018 Class I Terminated
FDA device recall Z-3010-2018 was initiated by Ventana Medical Systems Inc on August 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 November 22, 2021). Affected quantity: 2753 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- August 2, 2018
- Termination Date
- November 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2753 units
Product Description
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 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: Y12986, Y16448, Y24119, Y16912Z, UDI: 4015630970018