Home / Recalls / Phadia US Inc / Z-2041-2023

Z-2041-2023 Class II Ongoing

Recalled by Phadia US Inc — Portage, MI

Recall Details

Product Type
Devices
Report Date
July 5, 2023
Initiation Date
May 1, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

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

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

Distribution Pattern

US: CA, NJ, MI

Code Information

UDI: 07333066020938 All Serial Numbers

Other recalls by Phadia US Inc

  • Z-2040-2023 Class II — EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 1241000 (May 1, 2023)
  • Z-1107-2021 Class II — EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurem (December 14, 2020)
  • Z-1312-2018 Class II — ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Spe (December 18, 2017)
  • Z-1313-2018 Class II — ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP (December 18, 2017)
  • Z-0387-2018 Class II — Phadia 1000 Instrument, Article Number 12-3800-01. (July 5, 2017)
  • Z-1253-2017 Class II — EliA Sample Diluent, Article number, 83-1023-01 (January 30, 2017)
  • Z-0947-2015 Class II — Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 ( (November 20, 2014)
  • Z-2285-2012 Class III — PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test sys (August 2, 2012)