Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Control
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jul 1, 2026
- Reported
- Aug 12, 2026
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
- Status
- Ongoing
- Quantity
- 9 units
- Lot / codes
- UDI-DI: 05070002420385, Lot Number: KE132602
- Company location
- West Chester, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2896-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2896-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.