Class II

Medical Device Recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Aniara Diagnostica LLC · July 1, 2026

Reason for Recall

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, calibrators, and linearity values.

Distribution

US Nationwide distribution in the states of IL, NC, TN.

States Affected

NATIONWIDE

Quantity Affected

4 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2894-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.