Reported Aug 12, 2026 · Ongoing
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Aniara Diagnostica LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aniara Diagnostica LLC · 7768 Service Center Dr · West Chester, OH · 45069-2442
Is this the product you have?
5-PLASMA Bivalirudin AMR Verification KitModel Number 5D-45905
- Lot codes and dates
- UDI-DI05070002420378
- Lot NumberKE132603
- Amount recalled
- 4 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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