FDA Device recall Z-2894-2026
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 by Aniara Diagnostica, citing stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2894-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-01 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Aniara Diagnostica |
| Distribution | US |
Product
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
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.
Identifiers
| code_info | UDI-DI: 05070002420378, Lot Number: KE132603 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2894-2026%22
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