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Phadia Ab

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
33
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0783-2024Class IIEliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnosticMay 24, 2023
Z-2397-2019Class IIPhadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automatedJuly 9, 2019
Z-1907-2019Class IIEliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitroMay 10, 2019
Z-1276-2018Class IIPhadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 InstrumNovember 20, 2017
Z-0697-2016Class IIEliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro December 28, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen August 3, 2022
K210902EliA Ro52, EliA Ro60July 27, 2022
K202541EliA RNA Pol IIISeptember 13, 2021
K202540EliA Rib-PSeptember 13, 2021
K202067EliA SmDP-SJuly 14, 2021
K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineMay 1, 2020
K190710EliA SymphonyS ImmunoassayNovember 29, 2019
K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen ComponenMay 14, 2019
K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayMarch 1, 2019
K183007EliA SmDP ImmunoassayDecember 24, 2018
K182747EliA RF IgM ImmunoassayDecember 18, 2018
K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayNovember 27, 2018
K181556EliA M2 ImmunoassayJuly 13, 2018
K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayJune 25, 2018
K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutApril 16, 2018
K173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMarch 13, 2018
K173704ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP TrypMarch 2, 2018
K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEMay 5, 2017
K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/July 28, 2016
K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA ThyroidMarch 25, 2016