Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0783-2024 — EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

U.S. FDA — Device Enforcement · Sweden · 2023-05-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0783-2024
Date of alert
2023-05-24
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
Phadia Ab
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07333066010670
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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