Class II — Aniara Diagnostica LLC
| Recalling firm | Aniara Diagnostica LLC |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the states of IL, NC, TN. |
| Initiated | 2026-07-01 |
| Classified | 2026-08-05 |
| Recall number | Z-2895-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Aniara Diagnostica LLC (Z-2895-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99344/
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