Diamedix recalls

Diamedix has 7 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 8 Aug 2018.

Total recalls7since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 8 Aug 2018

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 71%Class III 2 29%

Why diamedix is recalled

Other Reasons457%
Potency & Assay343%

Product types

Test Kits & Diagnostics7100%

By year

2018229%
2016457%
2012114%

All diamedix recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
8 Aug 2018Device	CLASS III	Is-Ebv-ea-d IgG Enzyme Immunoassay Test Kit recalled by Diamedix	Diamedix	Potency & Assay	20 states
8 Aug 2018Device	CLASS III	Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use recalled	Diamedix	Potency & Assay	20 states
25 May 2016Device	CLASS II	Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is recalled	Diamedix	Other	Nationwide
25 May 2016Device	CLASS II	Is-CMV IgG Test Kit recalled by Diamedix	Diamedix	Other	20 states
25 May 2016Device	CLASS II	Is-Ebv-ea-d IgG Test Kit Diamedix Is-Mumps IgG Test Kit is recalled	Diamedix	Other	Nationwide
25 May 2016Device	CLASS II	Is-Ebv-vca IgG Test Kit Diamedix Is-Mumps IgG Test Kit is recalled	Diamedix	Other	Nationwide
5 Dec 2012Device	CLASS II	The Is-anti-Sm test kits**** recalled by Diamedix	Diamedix	Potency & Assay	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.