Home / Recalls / Phadia Ab / Z-0783-2024

Z-0783-2024 Class II Ongoing

Recalled by Phadia Ab — Uppsala, N/A

Recall Details

Product Type
Devices
Report Date
January 31, 2024
Initiation Date
May 24, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
124,928 kits

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.

Distribution Pattern

US Nationwide.

Code Information

UDI-DI: 07333066010670; All Lots.

Other recalls by Phadia Ab

  • Z-2397-2019 Class II — Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully inte (July 9, 2019)
  • Z-1907-2019 Class II — EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is inten (May 10, 2019)
  • Z-1276-2018 Class II — Phadia Prime software, article number 12-4101-00, as used in combination with th (November 20, 2017)
  • Z-0697-2016 Class II — EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intend (December 28, 2015)