Axis-Shield Diagnostics recalls

Axis-Shield Diagnostics has 4 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 1 Jan 2020. 3 are still ongoing.

Total recalls4since 2015

Last 12 months0reported

Class I00% of total

Ongoing3latest 1 Jan 2020

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 4 100%Class III 0 0%

Why axis-shield diagnostics is recalled

Other Reasons4100%

Product types

Test Kits & Diagnostics4100%

By year

2020375%
2015125%

Ongoing axis-shield diagnostics recalls

3 active

Reported	Class	Recall	Company	Reason	Where
1 Jan 2020Device	CLASS II	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled	Axis-Shield Diagnostics	Other	Nationwide
1 Jan 2020Device	CLASS II	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled	Axis-Shield Diagnostics	Other	Nationwide
1 Jan 2020Device	CLASS II	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled	Axis-Shield Diagnostics	Other	Nationwide

All axis-shield diagnostics recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
1 Jan 2020Device	CLASS II	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled	Axis-Shield Diagnostics	Other	Nationwide
1 Jan 2020Device	CLASS II	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled	Axis-Shield Diagnostics	Other	Nationwide
1 Jan 2020Device	CLASS II	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled	Axis-Shield Diagnostics	Other	Nationwide
8 Jul 2015Device	CLASS II	Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent recalled	Axis-Shield Diagnostics	Other	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.