OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
This recall has been terminated (originally issued September 14, 2018).
- Company
- Ventana Medical Systems Inc
- Recall Initiated
- August 2, 2018
- Posted
- September 14, 2018
- Terminated
- November 22, 2021
- Recall Number
- Z-3000-2018
- Quantity
- 461 units
- Firm Location
- Oro Valley, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Distribution
worldwide
Lot / Code Info
Lot Number: Y26282, UDI: 4015630984749
Root Cause
Under Investigation by firm
Action Taken
The firm disseminated their field safety notices by letter on 08/02/2018. The firm requested the destruction of the product.
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