5-PLASMA Bivalirudin AMR Verification Kit — Class II medical device recall Z-2894-2026
Ongoing recall by Aniara Diagnostica LLC, reported 2026-08-12, distributed nationwide. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified.
| Recall number | Z-2894-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aniara Diagnostica LLC, West Chester, OH, United States |
| Recall initiated | 2026-07-01 |
| Classified | 2026-08-05 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 05070002420378 |
| Lot numbers | KE132603 |
| Model numbers | 5D-45905 |
Product
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2894-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.