Manufacturer
11 recalls in our database name Aniara Diagnostica LLC as the manufacturing or recalling firm.
Of the 11 recalls from Aniara Diagnostica LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.
Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.
The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.
BIOPHEN UFH Control Plasma boxes contain incorrect product labeling. Aniara Diagnostica LLC is recalling 13 units (Lot FA2035) distributed in Illinois and Michigan.
Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.
Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.
Aniara Diagnostica LLC is recalling 41 units of BIOPHEN UFH Control C1 because incorrect versions of the Instructions for Use were packaged into specific lots.
Aniara Diagnostica LLC is recalling 14 kits of BIOPHEN UFH Control C2 because incorrect Instructions for Use were packaged with the product.
Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4 because incorrect versions of the Instructions for Use were packaged.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Aniara Diagnostica (United States)
company in West Chester, United States
Source: Wikidata (Q140869861), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.