Z-2894-2026 Class II Ongoing
FDA device recall Z-2894-2026 was initiated by Aniara Diagnostica LLC on July 1, 2026 and is designated Class II. 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, ca… The recall status is ongoing. Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- July 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of IL, NC, TN.
Code Information
UDI-DI: 05070002420378, Lot Number: KE132603