INFORM HPV III Fam 16 Probe - US Export recall
INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
Why was INFORM HPV III Fam 16 Probe - US Export 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: Y19417, UDI: 4015630972210
- Product
- INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Recalling firm
- Ventana Medical Systems Inc
- Quantity
- 195 units
- Distribution
- worldwide
- Recall date
- September 26, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)