Euro Diagnostica AB

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2627-2017Class IIIDIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) May 22, 2017
Z-0306-2018Class IIEuro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A February 14, 2017
Z-2919-2018Class IIIis a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantOctober 21, 2016
Z-2921-2018Class IIIis a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG andOctober 21, 2016
Z-2922-2018Class IIIis a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detecOctober 21, 2016
Z-2920-2018Class IIIis a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG andOctober 21, 2016
Z-2918-2018Class IIImmunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiqFebruary 14, 2016
Z-0929-2018Class IIDIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: October 15, 2015