Recall Z-2040-2023— Phadia US Inc

Name: FDA recall Z-2040-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-01

Class II · Ongoing

Class II FDA medical device recall by Phadia US Inc, initiated 2023-05-01. It names one FDA 510(k) clearance: K093459. Product: EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is 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 14553901. Reason: 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.

Recalling firm: Phadia US Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-05-01
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01Phadia US, Inc.·cleared 2010-08-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is 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 14553901

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.