Fujirebio Diagnostics recalls

Fujirebio Diagnostics has 7 recalls on record with the FDA and USDA, the earliest in 2026 and the latest reported on 11 Feb 2026. 7 are still ongoing. 7 were reported in the last 12 months. The most frequent reason is labeling errors.

Total recalls7since 2026

Last 12 months7reported

Class I00% of total

Ongoing7latest 11 Feb 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 0 0Jan '26 7 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 100%Class III 0 0%

Why fujirebio diagnostics is recalled

Labeling Errors7100%

Product types

By year

20267100%

Ongoing fujirebio diagnostics recalls

7 active

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Device	CLASS II	Lumipulse G pTau 217 Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse ¿-Amyloid Plasma Controls recalled by Fujirebio Diagnostics	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G pTau 217 Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide

All fujirebio diagnostics recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Device	CLASS II	Lumipulse G pTau 217 Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse ¿-Amyloid Plasma Controls recalled by Fujirebio Diagnostics	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G pTau 217 Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse pTau 217 Plasma Controls recalled by Fujirebio Diagnostics	Fujirebio Diagnostics	Labeling Errors	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.