TemporaryFDAOngoing
Can cause harm that is usually temporary.
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Check the device or its packaging for
UDI-DI: 05070002420392, Lot Number: KE132601
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of IL, NC, TN.
- Company
- Aniara Diagnostica LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2895-2026 · retrieved 5 August 2026
Read the official notice