EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Reported: January 31, 2024 Initiated: May 24, 2023 #Z-0783-2024
Product Description
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Reason for Recall
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.
Details
- Recalling Firm
- Phadia Ab
- Units Affected
- 124,928 kits
- Distribution
- US Nationwide.
- Location
- Uppsala, N/A
Frequently Asked Questions
What product was recalled? ▼
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic. Recalled by Phadia Ab. Units affected: 124,928 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2024. Severity: Moderate. Recall number: Z-0783-2024.
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