BioReference Health recalls

BioReference Health has 2 recalls on record with the FDA and USDA, the earliest in 2023 and the latest reported on 20 Dec 2023. 2 are still ongoing. The most frequent reason is potency & assay.

Total recalls2since 2023

Last 12 months0reported

Class I00% of total

Ongoing2latest 20 Dec 2023

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 2 100%Class III 0 0%

Why bioreference health is recalled

Potency & Assay150%
Lead & Heavy Metals150%

Product types

Test Kits & Diagnostics2100%

By year

20232100%

Ongoing bioreference health recalls

2 active

Reported	Class	Recall	Company	Reason	Where
20 Dec 2023Device	CLASS II	The 4Kscore Test, an in vitro serum or plasma test that recalled	BioReference Health	Potency & Assay	Nationwide
14 Jun 2023Device	CLASS II	The 4Kscore Test is an in vitro serum or plasma test that recalled	BioReference Health	Lead & Heavy Metals	Nationwide

All bioreference health recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
20 Dec 2023Device	CLASS II	The 4Kscore Test, an in vitro serum or plasma test that recalled	BioReference Health	Potency & Assay	Nationwide
14 Jun 2023Device	CLASS II	The 4Kscore Test is an in vitro serum or plasma test that recalled	BioReference Health	Lead & Heavy Metals	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.