FDA recall Z-0783-2024

Product

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.

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2023-05-24

Report date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Uppsala, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0783-2024