EliA GBM Wells recall
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Why was EliA GBM Wells recalled?
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: 07333066010670; All Lots.
- Product
- EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
- Recalling firm
- Phadia Ab
- Quantity
- 124,928 kits
- Distribution
- US Nationwide.
- Recall date
- January 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)