Aniara Diagnostica LLC Recalls
4 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (4)
- Class II
July 1, 2026
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
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.
- Class II
July 1, 2026
5-PLASMA Bivalirudin Control, Model Number 5D-44905
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.
- Class II
July 1, 2026
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
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.
- Class II
April 1, 2026
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
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