Reported Jan 31, 2024 · Ongoing
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Phadia Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Phadia Ab · Rapsgatan Plant · Uppsala, N/A · N/A
Is this the product you have?
EliA GBM WellsMaterial Number 14551401for Phadia 2502500and 5000. In vitro diagnostic
- Lot codes and dates
- UDI-DI07333066010670; All Lots
- Amount recalled
- 124,928 kits
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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