Every recall we track for Aniara Diagnostica LLC — 11 in all — plus the complaints and injury reports the public filed about them.
Aniara Diagnostica recalls 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues causing degraded bivalirudin measurements. Affected units have UDI-DI: 05070002420385 and Lot Number KE132602.
Aniara Diagnostica recalls 5-PLASMA Bivalirudin Calibrator Model 5D-46905 due to stability issues causing degraded bivalirudin measurements. Affected units have UDI-DI: 05070002420392 and Lot Number KE132601.
Aniara Diagnostica recalls 5-PLASMA Bivalirudin AMR Verification Kit (Model 5D-45905) due to stability problems causing inaccurate test results. Affected units may need replacement.
Aniara Diagnostica recalls ZYMUTEST HIA IgG ELISA kits with lot number FD1265 due to outdated positive control values in the test instructions.
Aniara Diagnostica recalls BIOPHEN Protein C 5 kits due to Cesium Chloride in Reagent 2 being classified as hazardous under CLP regulations, suspected of damaging fertility. Affected kits have UDI-DI: 366353700063BD Lot FA083327 and all future lots.
Aniara Diagnostica recalls BIOPHEN UFH Control Plasma due to incorrect product labeling in the package. This may cause confusion with similar products.
Aniara Diagnostica recalls ZYMUTEST HIA MonoStrip IgGAM ELISA kit (Model RK041D) for in vitro diagnostic use due to residual crystallization causing negative controls to go out of range. Affected users should contact for details.
Aniara Diagnostica recalls ZYMUTEST HIA MonoStrip IgG ELISA kits (Model RK041A) due to residual crystallization causing negative controls to go out of range. Affected kits sold under specific serial numbers.
Aniara Diagnostica recalls BIOPHEN UFH Control C2 (REF 223901) with incorrect Instructions for Use in specific lots. This may cause confusion during use. Contact for details.
Aniara Diagnostica recalls BIOPHEN LMWH Control C4 (REF 22420: Lots F1701555P4) due to incorrect Instructions for Use packaging. Consumers should check their product lot numbers.
Aniara Diagnostica recalls BIOPHEN UFH Control C1 devices with specific lot numbers due to incorrect Instructions for Use packaging. Affected units may have improper instructions that could lead to improper use.
