Accriva Diagnostics recalls

Accriva Diagnostics has 6 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 24 Jun 2026. 4 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls6since 2022

Last 12 months3reported

Class I00% of total

Ongoing4latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 0 1Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 1 1 0Jan '26 0 0 0Apr 0 1 0Jul 0 0

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why accriva diagnostics is recalled

Product types

By year

2026117%
2025350%
2024117%
2022117%

Ongoing accriva diagnostics recalls

4 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	directCHECK Act-lr whole blood quality control, level recalled	Accriva Diagnostics	Potency & Assay	Nationwide
10 Dec 2025Device	CLASS II	Hemochron Activated Clotting Time Low-Range Test Cuvette recalled	Accriva Diagnostics	Foreign Material	Nationwide
19 Nov 2025Device	CLASS III	VerifyNow PRUTest Platelet Reactivity Test recalled	Accriva Diagnostics	Packaging Defects	Nationwide
22 Jan 2025Device	CLASS II	VerifyNow P2Y12 Platelet Reactivity Test recalled by Accriva Diagnostics	Accriva Diagnostics	Other	Nationwide

All accriva diagnostics recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	directCHECK Act-lr whole blood quality control, level recalled	Accriva Diagnostics	Potency & Assay	Nationwide
10 Dec 2025Device	CLASS II	Hemochron Activated Clotting Time Low-Range Test Cuvette recalled	Accriva Diagnostics	Foreign Material	Nationwide
19 Nov 2025Device	CLASS III	VerifyNow PRUTest Platelet Reactivity Test recalled	Accriva Diagnostics	Packaging Defects	Nationwide
22 Jan 2025Device	CLASS II	VerifyNow P2Y12 Platelet Reactivity Test recalled by Accriva Diagnostics	Accriva Diagnostics	Other	Nationwide
6 Nov 2024Device	CLASS II	AVOXimeter 1000E, Product Number: AVOX1000E recalled	Accriva Diagnostics	Lead & Heavy Metals	AZ
1 Jun 2022Device	CLASS II	The VerifyNow P2Y12 Test is designed to measure platelet recalled	Accriva Diagnostics	Particulate Matter	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.