Phadia Ab
FDA Regulatory Profile
Phadia Ab appears in FDA public data with 5 recalls, 34 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0783-2024, Class II) was initiated on May 24, 2023. Its most recent 510(k) clearance was granted on June 25, 2026.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 34
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0783-2024 | Class II | EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic | May 24, 2023 |
| Z-2397-2019 | Class II | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated | July 9, 2019 |
| Z-1907-2019 | Class II | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro | May 10, 2019 |
| Z-1276-2018 | Class II | Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrum | November 20, 2017 |
| Z-0697-2016 | Class II | EliA 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-Number | Device | Date |
|---|
| K253367 | EliA CTD 13 Screen | June 25, 2026 |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen | August 3, 2022 |
| K210902 | EliA Ro52, EliA Ro60 | July 27, 2022 |
| K202541 | EliA RNA Pol III | September 13, 2021 |
| K202540 | EliA Rib-P | September 13, 2021 |
| K202067 | EliA SmDP-S | July 14, 2021 |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | May 1, 2020 |
| K190710 | EliA SymphonyS Immunoassay | November 29, 2019 |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Componen | May 14, 2019 |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | March 1, 2019 |
| K183007 | EliA SmDP Immunoassay | December 24, 2018 |
| K182747 | EliA RF IgM Immunoassay | December 18, 2018 |
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | November 27, 2018 |
| K181556 | EliA M2 Immunoassay | July 13, 2018 |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | June 25, 2018 |
| K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | April 16, 2018 |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | March 13, 2018 |
| K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryp | March 2, 2018 |
| K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | May 5, 2017 |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/ | July 28, 2016 |