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Euro Diagnostica AB Recalls
8 recalls on record · July 5, 2017 to August 29, 2018 · Medical Devices
Recalls by year
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 29, 2018Medical DevicesFDA
Euro Diagnostica AB recalls is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum
Hazard: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
August 29, 2018Medical DevicesFDA
Euro Diagnostica AB recalls is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies
Hazard: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
August 29, 2018Medical DevicesFDA
Euro Diagnostica AB recalls is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies
Hazard: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
August 29, 2018Medical DevicesFDA
Euro Diagnostica AB recalls is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for
Hazard: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
August 29, 2018Medical DevicesFDA
Euro Diagnostica AB recalls Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determin
Hazard: Decreasing performance overtime.
March 14, 2018Medical DevicesFDA
Euro Diagnostica AB recalls DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-n
Hazard: Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.
January 10, 2018Medical DevicesFDA
Euro Diagnostica AB recalls Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test re
Hazard: Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
July 5, 2017Medical DevicesFDA
Euro Diagnostica AB recalls DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitativ
Hazard: FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.