FDAOctober 21, 2016device
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
What to do
FDA enforcement status: Terminated
Brands named
euro diagnostica abeuroeuro diagnostica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A2026-04-01
- FDABrand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ ...2026-02-05
- FDABrand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated p...2026-02-04
- FDAAsserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.2025-12-15
- FDAProduct: STA Liatest D-Di; REF: 00515;2025-09-12
- FDASTA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their ...2025-07-21
- FDASTA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their ...2025-07-21
- FDASTA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.2025-07-21
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