OptiView Amplification Kit recall
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
Why was OptiView Amplification Kit recalled?
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: Y26282, UDI: 4015630984749
- Product
- OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Recalling firm
- Ventana Medical Systems Inc
- Quantity
- 461 units
- Distribution
- worldwide
- Recall date
- September 26, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)