Home / Recalls / Phadia US Inc / Z-0387-2018

Z-0387-2018 Class II Terminated

Recalled by Phadia US Inc — Portage, MI

Recall Details

Product Type
Devices
Report Date
January 24, 2018
Initiation Date
July 5, 2017
Termination Date
October 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70 units

Product Description

Phadia 1000 Instrument, Article Number 12-3800-01.

Reason for Recall

The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

Distribution Pattern

Nationwide

Code Information

All versions of the instrument

Other recalls by Phadia US Inc

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  • Z-1107-2021 Class II — EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurem (December 14, 2020)
  • Z-1313-2018 Class II — ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP (December 18, 2017)
  • Z-1312-2018 Class II — ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Spe (December 18, 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)