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Aniara Diagnostica LLC FDA Recalls
6 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Class IIJul 1, 2026Stability issues with the reconstituted lyophilized human pl |
| 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Class IIJul 1, 2026Stability issues with the reconstituted lyophilized human pl |
| 5-PLASMA Bivalirudin Control, Model Number 5D-44905Class IIJul 1, 2026Stability issues with the reconstituted lyophilized human pl |
| ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040AClass IIApr 1, 2026Kits from lot FD1265 had been packaged on 17 October 2024 an |
| BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. ProteClass IIFeb 1, 2023New warnings and precautionary statements on product labelli |
| BIOPHEN UFH Control PlasmaClass IIIJun 28, 2022Incorrect product labeling was included in the package. |