Magellan Diagnostics recalls

Magellan Diagnostics has 16 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 29 Apr 2026. 5 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is lead & heavy metals.

Total recalls16since 2017

Last 12 months4reported

Class I744% of total

Ongoing5latest 29 Apr 2026

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 1 0Jan '26 0 0 3Apr 0 0 0Jul 0 0

Severity split

Class I 7 44%Class II 9 56%Class III 0 0%

Why magellan diagnostics is recalled

Product types

Test Kits & Diagnostics16100%

By year

2026319%
202516%
202316%
2021319%
2018319%
2017531%

Ongoing magellan diagnostics recalls

5 active

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Device	CLASS II	LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
29 Apr 2026Device	CLASS II	(2) LeadCare¿ II Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
29 Apr 2026Device	CLASS II	LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
3 Dec 2025Device	CLASS II	The LeadCare¿ II Blood Lead Test System relies on recalled	Magellan Diagnostics	Labeling Errors	Nationwide
15 Nov 2023Device	CLASS II	LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only recalled	Magellan Diagnostics	Foreign Material	Nationwide

All magellan diagnostics recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Device	CLASS II	LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
29 Apr 2026Device	CLASS II	(2) LeadCare¿ II Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
29 Apr 2026Device	CLASS II	LeadCare¿ Plus Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
3 Dec 2025Device	CLASS II	The LeadCare¿ II Blood Lead Test System relies on recalled	Magellan Diagnostics	Labeling Errors	Nationwide
15 Nov 2023Device	CLASS II	LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only recalled	Magellan Diagnostics	Foreign Material	Nationwide
7 Jul 2021Device	CLASS I	LeadCare II Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
7 Jul 2021Device	CLASS I	LeadCare Plus Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
7 Jul 2021Device	CLASS I	LeadCare Ultra Blood Lead Test Kit recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
7 Nov 2018Device	CLASS II	Magellan LeadCare¿ II Blood Lead Test Kit recalled	Magellan Diagnostics	Lead & Heavy Metals	Nationwide
11 Apr 2018Device	CLASS II	LeadCare Plus Blood Lead Analyzer recalled by Magellan Diagnostics	Magellan Diagnostics	Lead & Heavy Metals	MA

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.