Phadia US recalls

Phadia US has 9 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 5 Jul 2023. 2 are still ongoing.

Total recalls9since 2012

Last 12 months0reported

Class I00% of total

Ongoing2latest 5 Jul 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 89%Class III 1 11%

Why phadia us is recalled

Product types

Test Kits & Diagnostics556%
Other Medical Devices444%

By year

2023222%
2021111%
2018333%
2017111%
2015111%
2012111%

Ongoing phadia us recalls

2 active

Reported	Class	Recall	Company	Reason	Where
5 Jul 2023Device	CLASS II	EliA GliadinDP IgG Well in the Phadia 2500EE instrument recalled	Phadia US	Other	CA, MI, NJ
5 Jul 2023Device	CLASS II	Phadia 2500EE instrument -Intended recalled by Phadia US	Phadia US	Other	CA, MI, NJ

All phadia us recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
5 Jul 2023Device	CLASS II	EliA GliadinDP IgG Well in the Phadia 2500EE instrument recalled	Phadia US	Other	CA, MI, NJ
5 Jul 2023Device	CLASS II	Phadia 2500EE instrument -Intended recalled by Phadia US	Phadia US	Other	CA, MI, NJ
17 Feb 2021Device	CLASS II	EliA dsDNA Well recalled by Phadia US	Phadia US	Other	Nationwide
11 Apr 2018Device	CLASS II	ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016) recalled	Phadia US	Labeling Errors	Nationwide
11 Apr 2018Device	CLASS II	ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01) recalled	Phadia US	Labeling Errors	Nationwide
24 Jan 2018Device	CLASS II	Phadia 1000 Instrument, Article Number recalled by Phadia US	Phadia US	Potency & Assay	Nationwide
8 Mar 2017Device	CLASS II	EliA Sample Diluent, Article number recalled by Phadia US	Phadia US	Other	27 states
21 Jan 2015Device	CLASS II	Phadia 1000 Instrument (introduced as UniCAP 1000) recalled by Phadia US	Phadia US	Labeling Errors	Nationwide
5 Sep 2012Device	CLASS III	Phadia Varelisa Cardiolipin IgM Cardiolipin autoantibody recalled	Phadia US	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.