Official recall notice
FDA DeviceClass IINotable
FDA Recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- Recall date
- 2026-08-12
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
UDI-DI: 05070002420378, Lot Number: KE132603