Home / Recalls / Phadia US Inc / Z-1313-2018

Z-1313-2018 Class II Terminated

Recalled by Phadia US Inc — Portage, MI

Recall Details

Product Type
Devices
Report Date
April 11, 2018
Initiation Date
December 18, 2017
Termination Date
March 27, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
950 total

Product Description

ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

Reason for Recall

The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.

Distribution Pattern

Nationwide Distribution

Code Information

Lots 991DA, exp.2018.04.30 991DC, exp. 2018.07.31 991D7 991D9, exp.2018.02.28

Other recalls by Phadia US Inc

  • Z-2041-2023 Class II — Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measuremen (May 1, 2023)
  • 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-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)