Phadia US Inc: Medical Device Recall in 2023 - (Recall #: Z-2041-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002

Product Classification:

Class II

Date Initiated: May 1, 2023

Date Posted: July 5, 2023

Recall Number: Z-2041-2023

Event ID: 92365

Reason for Recall:

Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

Status: Ongoing

Product Quantity: 9 units

Code Information:

UDI: 07333066020938 All Serial Numbers

Distribution Pattern:

US: CA, NJ, MI

Voluntary or Mandated:

Voluntary: Firm initiated