Aniara Diagnostica Llc: Plasma, Coagulation Control
Recall Summary Aniara Diagnostica LLC is recalling its 5-PLASMA Bivalirudin Control (Model 5D-44905), a medical device used to test blood coagulation, because the reconstituted product breaks down over time and loses measurable bivalirudin levels, which can affect test accuracy. The product was distributed nationwide, primarily in Illinois, North Carolina, and Tennessee. This is a Class II recall, indicating a potential issue that could affect proper device function.
- Recalling firm
- Aniara Diagnostica LLC
- Product
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fa5843c3-7f8f-46e5-9148-7b1a45c3431c