Diagnostic Hybrids recalls

Diagnostic Hybrids has 8 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 16 May 2018. The most frequent reason is potency & assay.

Total recalls8since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 16 May 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 3 38%Class III 5 63%

Why diagnostic hybrids is recalled

Product types

By year

2018675%
2015113%
2013113%

All diagnostic hybrids recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
16 May 2018Device	CLASS II	MicroVue BAP EIA recalled by Diagnostic Hybrids	Diagnostic Hybrids	Packaging Defects	12 states
2 May 2018Device	CLASS III	MicroVue CIC-C1q EIA recalled by Diagnostic Hybrids	Diagnostic Hybrids	Other	Nationwide
2 May 2018Device	CLASS III	MicroVue SC5b-9 Plus EIA (RUO) recalled by Diagnostic Hybrids	Diagnostic Hybrids	Potency & Assay	Nationwide
2 May 2018Device	CLASS III	MicroVue SC5b-9 Plus EIA (Ce-ivd) recalled by Diagnostic Hybrids	Diagnostic Hybrids	Potency & Assay	Nationwide
2 May 2018Device	CLASS II	MicroVue CIC-C1q EIA recalled by Diagnostic Hybrids	Diagnostic Hybrids	Potency & Assay	4 states
2 May 2018Device	CLASS III	Quidel MicroVue Intact PTH EIA recalled by Diagnostic Hybrids	Diagnostic Hybrids	Potency & Assay	OH
9 Sep 2015Device	CLASS II	MicroVue Bb Plus EIA is packaged as a kit which contains recalled	Diagnostic Hybrids	Packaging Defects	11 states
13 Feb 2013Device	CLASS III	Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A recalled	Diagnostic Hybrids	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.