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RecallsAboutBlog

Aniara Diagnostica LLC

Aniara Diagnostica LLC: 2 recalls listed since May 2026 across FDA.

By year

  • 20262

By agency

  • FDA2

By category

  • Medical Device2

All recalls (2)

Aniara Diagnostica 5-PLASMA Bivalirudin Kits, Calibrators and Controls

The 5-Plasma Bivalirudin AMR Verification Kit has stability issues that degrade measurable bivalirudin.

Moderate risk, FDA, , Quality testing problem

ZYMUTEST HIA IgG, in Vitro Diagnostic ELISA Kit

The ZYMUTEST HIA IgG kit may have incorrect values for the positive control.

Moderate risk, FDA, , Device defect
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