FDAFDA · Food and drugs·Recall number Z-2896-2026
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Published August 12, 2026 · Recall initiated: July 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aniara Diagnostica LLC
- Distributor
- US Nationwide distribution in the states of IL, NC, TN.
- Lot
- UDI-DI: 05070002420385, Lot Number: KE132602
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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