LumiraDx recalls

LumiraDx has 6 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 21 Jun 2023. 1 is still ongoing.

Total recalls6since 2021

Last 12 months0reported

Class I00% of total

Ongoing1latest 21 Jun 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 5 83%Class III 1 17%

Why lumiradx is recalled

Other Reasons583%
Sterility117%

Product types

By year

2023117%
2022350%
2021233%

Ongoing lumiradx recalls

1 active

Reported	Class	Recall	Company	Reason	Where
21 Jun 2023Device	CLASS II	SteriPack Sterile Polyester Spun Swabs/Pack)- Intended recalled	LumiraDx	Sterility	Nationwide

All lumiradx recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
21 Jun 2023Device	CLASS II	SteriPack Sterile Polyester Spun Swabs/Pack)- Intended recalled	LumiraDx	Sterility	Nationwide
2 Nov 2022Device	CLASS III	Sars-CoV-2 Antigen (Ag) Liquid Quality Control Kit recalled by LumiraDx	LumiraDx	Other	Nationwide
27 Jul 2022Device	CLASS II	Sars-CoV-2 Antibody (Ab) Test Strip recalled by LumiraDx	LumiraDx	Other	13 states
27 Jul 2022Device	CLASS II	Sars-CoV-2 Antibody (Ab) Liquid Quality Control recalled by LumiraDx	LumiraDx	Other	13 states
7 Apr 2021Device	CLASS II	Coronavirus antigen detection test system recalled by LumiraDx	LumiraDx	Other	Nationwide
24 Feb 2021Device	CLASS II	Sars-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN) recalled by LumiraDx	LumiraDx	Other	4 states

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.