Recall Z-2895-2026— Aniara Diagnostica LLC
Class II · Ongoing
Class II FDA medical device recall by Aniara Diagnostica LLC, initiated 2026-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905. 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..
- Recalling firm
- Aniara Diagnostica LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-01
- Firm location
- West Chester, OH, United States
Product description
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.