Sekisui Diagnostics recalls

Sekisui Diagnostics has 4 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 23 Oct 2013. The most frequent reason is potency & assay.

Total recalls4since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 23 Oct 2013

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 4 100%Class III 0 0%

Why sekisui diagnostics is recalled

Potency & Assay375%
Botulism125%

Product types

Test Kits & Diagnostics4100%

By year

2013125%
2012375%

All sekisui diagnostics recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
23 Oct 2013Device	CLASS II	OSOM C. Difficile Toxin A/B Test recalled by Sekisui Diagnostics	Sekisui Diagnostics	Botulism	Nationwide
12 Dec 2012Device	CLASS II	Spectrolyse Pai--Vitro Diagnostic Use recalled by Sekisui Diagnostics	Sekisui Diagnostics	Potency & Assay	Nationwide
26 Sep 2012Device	CLASS II	Sekisui Spectrolyse Pai--Vitro Diagnostic recalled	Sekisui Diagnostics	Potency & Assay	Nationwide
4 Jul 2012Device	CLASS II	Multigent Acetaminophen for use with Architect/Aeroset recalled	Sekisui Diagnostics	Potency & Assay	IL

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.