Iris Diagnostics recalls

Iris Diagnostics has 4 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 2 Sep 2015. The most frequent reason is potency & assay.

Total recalls4since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Sep 2015

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 3 75%Class III 1 25%

Why iris diagnostics is recalled

Potency & Assay375%
Device Malfunction125%

Product types

Test Kits & Diagnostics375%
Patient Monitors125%

By year

2015125%
2014125%
2013125%
2012125%

All iris diagnostics recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
2 Sep 2015Device	CLASS II	iChemVELOCITY Automated Urine Chemistry recalled by Iris Diagnostics	Iris Diagnostics	Potency & Assay	Nationwide
31 Dec 2014Device	CLASS II	RTH8 Rotor recalled by Iris Diagnostics	Iris Diagnostics	Device Malfunction	Nationwide
22 May 2013Device	CLASS II	Division iQ Control/Focus Set recalled by Iris Diagnostics	Iris Diagnostics	Potency & Assay	Nationwide
8 Aug 2012Device	CLASS III	IRISpec" CA/CB two-part urine chemistry control twin set recalled	Iris 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.