Aniara Diagnostica recalls
4 official recalls and safety alerts involving Aniara Diagnostica since 2022-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Aniara Diagnostica or the relevant agency.
- 2026-08-12
USAniara Diagnostica LLC recalls 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…
FDA · DeviceAniara Diagnostica LLCUS Nationwide distribution in the states of IL, NC, TN.Official notice →- 2026-05-20
- US
Aniara Diagnostica LLC recalls 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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
FDA · DeviceAniara Diagnostica LLCUS Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA,…Official notice → - 2023-03-15
- US
Aniara Diagnostica LLC recalls BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a…
New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to…
- 2022-09-21
- US
Aniara Diagnostica LLC recalls BIOPHEN UFH Control Plasma
Incorrect product labeling was included in the package.