BEUDAMED
    5 results · 7ms · Sources: EU EUDAMED, US FDA

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    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·April 11, 2018

    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·February 3, 2016

    Mycoplasma test, IgG and IgM

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·August 29, 2018