Aniara Diagnostica recalls

Aniara Diagnostica has 11 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 12 Aug 2026. 5 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is packaging defects.

Total recalls11since 2019

Last 12 months4reported

Class I00% of total

Ongoing5latest 12 Aug 2026

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 1 0 0Jul 3 0

Severity split

Class I 0 0%Class II 7 64%Class III 4 36%

Why aniara diagnostica is recalled

Product types

Other Medical Devices764%
Test Kits & Diagnostics436%

By year

2026436%
202319%
202219%
2019545%

Ongoing aniara diagnostica recalls

5 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	5-Plasma Bivalirudin Control recalled by Aniara Diagnostica	Aniara Diagnostica	Lead & Heavy Metals	Nationwide
12 Aug 2026Device	CLASS II	5-Plasma Bivalirudin Calibrator recalled by Aniara Diagnostica	Aniara Diagnostica	Lead & Heavy Metals	Nationwide
12 Aug 2026Device	CLASS II	5-Plasma Bivalirudin AMR Verification Kit recalled by Aniara Diagnostica	Aniara Diagnostica	Lead & Heavy Metals	Nationwide
20 May 2026Device	CLASS II	Zymutest Hia IgG, in vitro diagnostic Elisa kit recalled	Aniara Diagnostica	Packaging Defects	Nationwide
15 Mar 2023Device	CLASS II	Biophen Protein C 5 kit is recalled by Aniara Diagnostica	Aniara Diagnostica	Other	Nationwide

All aniara diagnostica recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	5-Plasma Bivalirudin Control recalled by Aniara Diagnostica	Aniara Diagnostica	Lead & Heavy Metals	Nationwide
12 Aug 2026Device	CLASS II	5-Plasma Bivalirudin Calibrator recalled by Aniara Diagnostica	Aniara Diagnostica	Lead & Heavy Metals	Nationwide
12 Aug 2026Device	CLASS II	5-Plasma Bivalirudin AMR Verification Kit recalled by Aniara Diagnostica	Aniara Diagnostica	Lead & Heavy Metals	Nationwide
20 May 2026Device	CLASS II	Zymutest Hia IgG, in vitro diagnostic Elisa kit recalled	Aniara Diagnostica	Packaging Defects	Nationwide
15 Mar 2023Device	CLASS II	Biophen Protein C 5 kit is recalled by Aniara Diagnostica	Aniara Diagnostica	Other	Nationwide
21 Sep 2022Device	CLASS III	Biophen UFH Control Plasma recalled by Aniara Diagnostica	Aniara Diagnostica	Packaging Defects	IL, MI
28 Aug 2019Device	CLASS II	Zymutest Hia MonoStrip, IgGAM Elisa kit recalled by Aniara Diagnostica	Aniara Diagnostica	Other	4 states
28 Aug 2019Device	CLASS II	Zymutest Hia MonoStrip, IgG Elisa kit recalled by Aniara Diagnostica	Aniara Diagnostica	Other	4 states
24 Apr 2019Device	CLASS III	Biophen UFH Control C2 recalled by Aniara Diagnostica	Aniara Diagnostica	Packaging Defects	MI, PA
24 Apr 2019Device	CLASS III	Biophen Lmwh Control C4 recalled by Aniara Diagnostica	Aniara Diagnostica	Packaging Defects	MI, PA

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.