Z-3001-2018 Class I Terminated
FDA device recall Z-3001-2018 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: 10 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
- 10 units
Product Description
iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory 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 Number: Y19981, UDI: 4015630970261
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3001-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026