FDAHealthJuly 1, 2026
Aniara Diagnostica LLC — 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 1, 2026
US Nationwide distribution in the states of IL, NC, TN.
What's affected?
- Product
- 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
- Lot code
- KE132601
Additional details
UDI-DI: 05070002420392, Lot Number: KE132601
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7 units.
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