Lusys Laboratories recalls

Lusys Laboratories has 11 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 16 Mar 2022. 3 are still ongoing.

Total recalls11since 2015

Last 12 months0reported

Class I11100% of total

Ongoing3latest 16 Mar 2022

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 11 100%Class II 0 0%Class III 0 0%

Why lusys laboratories is recalled

Other Reasons873%
Packaging Defects327%

Product types

By year

2022327%
2015873%

Ongoing lusys laboratories recalls

3 active

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Device	CLASS I	Covid-19 IgG/Igm Antibody Test For Detection of Covid recalled	Lusys Laboratories	Other	Nationwide
16 Mar 2022Device	CLASS I	LuSys 2nd Generation of Covid-19 Viral Antigen Test For all recalled	Lusys Laboratories	Other	Nationwide
16 Mar 2022Device	CLASS I	Luscient Diagnostics 2nd Generation of Covid-19 Viral recalled	Lusys Laboratories	Other	Nationwide

All lusys laboratories recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Device	CLASS I	Covid-19 IgG/Igm Antibody Test For Detection of Covid recalled	Lusys Laboratories	Other	Nationwide
16 Mar 2022Device	CLASS I	LuSys 2nd Generation of Covid-19 Viral Antigen Test For all recalled	Lusys Laboratories	Other	Nationwide
16 Mar 2022Device	CLASS I	Luscient Diagnostics 2nd Generation of Covid-19 Viral recalled	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola GP IgM Blood (Blood Serum/Plasma/Cassette) recalled	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola Accessories assembled, self-contained package recalled	Lusys Laboratories	Packaging Defects	Nationwide
15 Apr 2015Device	CLASS I	Ebola IgX VP-40 Serum/Plasma/Blood Cassette recalled	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola Virus Antigen Nasal recalled by Lusys Laboratories	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette) recalled	Lusys Laboratories	Packaging Defects	Nationwide
15 Apr 2015Device	CLASS I	Ebola Virus Gp-vp IgS recalled by Lusys Laboratories	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola Virus Antigen Blood recalled by Lusys Laboratories	Lusys Laboratories	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.