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FDA · Medical devices ·

5-PLASMA Bivalirudin AMR Verification Kit recall

Aniara Diagnostica LLC recalled 5-PLASMA Bivalirudin AMR Verification Kit on August 12, 2026 because of stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. It was sold nationwide.

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.

What's recalled

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Quantity: 4 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Aniara Diagnostica LLC, West Chester, OH
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide distribution in the states of IL, NC, TN.
Status
Ongoing
Recall number
Z-2894-2026
Source
U.S. Food and Drug Administration

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