5-PLASMA Bivalirudin AMR Verification Kit
Aniara recalls 5-PLASMA Bivalirudin AMR Verification Kit (Model 5D-45905) due to stability issues causing degradation of bivalirudin.
Do not use the affected kit. Contact Aniara Diagnostica LLC for instructions on returning the product and obtaining a replacement or refund.
Why it was recalled
Aniara Diagnostica LLC is recalling the 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905, due to stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix. These stability issues cause degradation of measurable bivalirudin in the controls, calibrators, and linearity values, which could lead to inaccurate test results.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | KE132603 | Z-2894-2026 | 05070002420378 |
| 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 | KE132601 | Z-2895-2026 | 05070002420392 |
| 5-PLASMA Bivalirudin Control, Model Number 5D-44905 | KE132602 | Z-2896-2026 | 05070002420385 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Failed Specifications recalls
Other recent recalls from Aniara Diagnostica LLC
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification