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Aniara Diagnostica LLC: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Medical DevicesSource: FDA (device) · Date: 2026-08-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Aniara Diagnostica LLC
Product
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of IL, NC, TN.
Recall initiated
2026-07-01
Code info
UDI-DI: 05070002420378, Lot Number: KE132603
Product quantity
4 units
Voluntary mandated
Voluntary: Firm initiated
City
West Chester
State
OH
Country
United States
Event id
99344
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