Home / Brands / Aniara Diagnostica
Aniara Diagnostica Recalls
11 recalls on record · April 24, 2019 to August 12, 2026 · Medical Devices
Recalls by year
19
22
23
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026Medical DevicesFDA
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Control, Model Number 5D-44905
Hazard: 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.
August 12, 2026Medical DevicesFDA
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Hazard: 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.
August 12, 2026Medical DevicesFDA
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Hazard: 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.
May 20, 2026Medical DevicesFDA
Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Hazard: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
March 15, 2023Medical DevicesFDA
Aniara Diagnostica LLC recalls BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Prote
Hazard: 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 the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility
September 21, 2022Medical DevicesFDA
Aniara Diagnostica LLC recalls BIOPHEN UFH Control Plasma
Hazard: Incorrect product labeling was included in the package.
August 28, 2019Medical DevicesFDA
Aniara Diagnostica LLC recalls ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
Hazard: Residual crystallization of the microplate and recurrent negative controls out of range.
August 28, 2019Medical DevicesFDA
Aniara Diagnostica LLC recalls ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Hazard: Residual crystallization of the microplate and recurrent negative controls out of range.
April 24, 2019Medical DevicesFDA
Aniara Diagnostica LLC recalls BIOPHEN LMWH Control C4, REF 224201
Hazard: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
April 24, 2019Medical DevicesFDA
Aniara Diagnostica LLC recalls BIOPHEN UFH Control C1, REF 224101
Hazard: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
April 24, 2019Medical DevicesFDA
Aniara Diagnostica LLC recalls BIOPHEN UFH Control C2, REF 223901
Hazard: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.