Fresh Recalls

Aniara Diagnostica recalls

4 recent recalls on record for Aniara Diagnostica in connected official government data as of September 7, 2026 at 6:00 AM UTC.

Models with recalls

5-PLASMA Bivalirudin AMR Verification Kit (1)5-PLASMA Bivalirudin Calibrator (1)5-PLASMA Bivalirudin Control (1)ZYMUTEST HIA IgG (1)

All Aniara Diagnostica recalls

FDA Class II · Medical device · August 12, 2026

5-PLASMA Bivalirudin Control recall — Aniara Diagnostica LLC

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…

Official ID Z-2896-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

5-PLASMA Bivalirudin Calibrator recall — Aniara Diagnostica LLC

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…

Official ID Z-2895-2026 · Official record ↗

FDA Class II · Medical device · August 12, 2026

5-PLASMA Bivalirudin AMR Verification Kit recall — Aniara Diagnostica LLC

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…

Official ID Z-2894-2026 · Official record ↗

FDA Class II · Medical device · May 20, 2026

ZYMUTEST HIA IgG recall — Aniara Diagnostica LLC

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Official ID Z-2171-2026 · Official record ↗

Verify with the official sources:

Found something wrong or missing? Report a data error.

Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.