iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reported: September 26, 2018 Initiated: August 2, 2018 #Z-2998-2018
Product Description
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 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.
Details
- Recalling Firm
- Ventana Medical Systems Inc
- Units Affected
- 3068 units
- Distribution
- worldwide
- Location
- Oro Valley, AZ
Frequently Asked Questions
What product was recalled? ▼
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.. Recalled by Ventana Medical Systems Inc. Units affected: 3068 units.
Why was this product recalled? ▼
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Critical. Recall number: Z-2998-2018.
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