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Medical Device

5-PLASMA Bivalirudin Control, Model Number 5D-44905

Recall date: 2026-08-12 · Source: FDA_DEVICE
Brand / Firm
Aniara Diagnostica LLC
Product
5-PLASMA Bivalirudin Control, Model Number 5D-44905
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.
Units affected
9 units
Description
5-PLASMA Bivalirudin Control, Model Number 5D-44905
View official recall notice →