VENTANA anti-Helicobacter Pylori recall
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
Why was VENTANA anti-Helicobacter Pylori 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 Numbers: Y12986, Y16448, Y24119, Y16912Z, UDI: 4015630970018
- Product
- VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Recalling firm
- Ventana Medical Systems Inc
- Quantity
- 2753 units
- Distribution
- worldwide
- Recall date
- September 26, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)