Phadia Ab: Medical Device Recall in 2024 - (Recall #: Z-0783-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

Product Classification:

Class II

Date Initiated: May 24, 2023

Date Posted: January 31, 2024

Recall Number: Z-0783-2024

Event ID: 93403

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.

Status: Ongoing

Product Quantity: 124,928 kits

Code Information:

UDI-DI: 07333066010670; All Lots.

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated