# FDA device recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

> recall · VERIFIED · 2026-07-01

Firm: Aniara Diagnostica LLC · Class II · Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, ca

- Company: Aniara Diagnostica LLC
- Sector: diagnostics
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.