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Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Recalled August 12, 2026 · FDA recall Z-2895-2026 · Aniara Diagnostica
Hazard
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. · FDA Class II
Units
7 units
Sold at
US Nationwide distribution in the states of IL, NC, TN.
Description
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.
Product
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Manufacturer(s)
Aniara Diagnostica LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →