Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Euro-Diagnostica with 11 510(k) clearances, 8 device recalls and 2 warning letters. The most recent is a warning letter dated Sep 14, 2018: Warning letter: Medical Devices.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 14, 2018 | Warning letter: Medical DevicesCDRH | Warning letters |
| Sep 20, 2017 | Warning letter: CAPA, Complaint handling, MDR reportingCDRH | Warning letters |
| May 22, 2017 | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immuClass III · FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed | Device recalls |
| Feb 14, 2017 | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumClass II · Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit | Device recalls |
| Oct 21, 2016 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antiClass III · Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Device recalls |
| Oct 21, 2016 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phoClass III · Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Device recalls |
| Oct 21, 2016 | is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibClass III · Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Device recalls |
| Oct 21, 2016 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phoClass III · Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Device recalls |
| Feb 14, 2016 | Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodClass II · Decreasing performance overtime. | Device recalls |
| Oct 15, 2015 | DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANAClass II · Complaint investigation concluded that although product quality requirements stated in the instructions for use were me | Device recalls |
| Dec 1, 2010 | CCPOINTK093908 · NHX | 510(k) clearances |
| Nov 19, 2009 | IMMUNOSCAN CCPLUSK091657 · NHX | 510(k) clearances |
| Dec 4, 2006 | EDIA ANTI-CCPK062045 · NHX | 510(k) clearances |
| Oct 29, 1997 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KITK971464 · DBL | 510(k) clearances |
| Oct 29, 1997 | IMMUNOSCAN PR3-ANCAK971690 · MOB | 510(k) clearances |
| Oct 29, 1997 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KITK971689 · MOB | 510(k) clearances |
| Jul 9, 1985 | BLHI LUTEINIZING HORMONEK851332 · CEP | 510(k) clearances |
| Apr 29, 1985 | TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONEK851148 · JLW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
