Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
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…
Read the official notice →- Date
- 2026-08-12
- Country
- United States
- Brand
- Aniara Diagnostica
- Product
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IL, NC, TN.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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