Focus Diagnostics recalls

Focus Diagnostics has 11 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 5 Apr 2017.

Total recalls11since 2012

Last 12 months0reported

Class I218% of total

Ongoing0latest 5 Apr 2017

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 2 18%Class II 8 73%Class III 1 9%

Why focus diagnostics is recalled

Product types

By year

2017218%
2016327%
2015218%
2014327%
201219%

All focus diagnostics recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
5 Apr 2017Device	CLASS II	Legionella IFA (IF0950) intended recalled by Focus Diagnostics	Focus Diagnostics	Other	CA, NJ, VA
5 Apr 2017Device	CLASS II	Legionella IFA Substrate Slide (IF0951) intended recalled	Focus Diagnostics	Other	CA, NJ, VA
13 Apr 2016Device	CLASS II	Simplexa Flu A/B & RSV Direct (MOL2650) recalled by Focus Diagnostics	Focus Diagnostics	Other	Nationwide
13 Apr 2016Device	CLASS I	Simplexa HSV 1&2 Direct (MOL2150) recalled by Focus Diagnostics	Focus Diagnostics	Other	Nationwide
13 Apr 2016Device	CLASS I	Simplexa Group A Strep Direct (MOL2850) recalled by Focus Diagnostics	Focus Diagnostics	Other	Nationwide
18 Nov 2015Device	CLASS II	Anaplasma Phagocytophilum IFA IgM Test Kit recalled by Focus Diagnostics	Focus Diagnostics	Other	CA
29 Apr 2015Device	CLASS II	Stratify JCV DxSelect recalled by Focus Diagnostics	Focus Diagnostics	Lead & Heavy Metals	Nationwide
9 Jul 2014Device	CLASS II	Simplexa" Flu A/B & RSV Direct recalled by Focus Diagnostics	Focus Diagnostics	Potency & Assay	Nationwide
12 Mar 2014Device	CLASS II	Simplexa Flu AlB & RSV Direct Assay Kits, intended recalled	Focus Diagnostics	Potency & Assay	Nationwide
5 Feb 2014Device	CLASS II	Simplexa Flu A/B & RSV Direct assay recalled by Focus Diagnostics	Focus Diagnostics	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.