Hyphen BioMed recalls

Hyphen BioMed has 5 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 16 May 2018. The most frequent reason is potency & assay.

Total recalls5since 2018

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 5 100%Class III 0 0%

Why hyphen biomed is recalled

Potency & Assay5100%

Product types

Test Kits & Diagnostics5100%

By year

20185100%

All hyphen biomed recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
16 May 2018Device	CLASS II	Zymutest HIA MonoStrip IgG recalled by Hyphen BioMed	Hyphen BioMed	Potency & Assay	5 states
16 May 2018Device	CLASS II	Zymutest HIA IgGAM recalled by Hyphen BioMed	Hyphen BioMed	Potency & Assay	5 states
16 May 2018Device	CLASS II	Zymutest HIA MonoStria qualitative screening assay intended recalled	Hyphen BioMed	Potency & Assay	5 states
21 Mar 2018Device	CLASS II	Zymutest HIA MonoStrip IgGAM recalled by Hyphen BioMed	Hyphen BioMed	Potency & Assay
21 Mar 2018Device	CLASS II	Zymutest HIA IgGAM recalled by Hyphen BioMed	Hyphen BioMed	Potency & Assay

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.