Phadia AB
Portage, MI, US
PHADIA AB appears in FDA device records in Portage, MI. FDA records list 56 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Phadia AB carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Phadia US, Inc.registration, 510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 56FDA records hold 56 510(k) clearances for Phadia AB between 2006 and 2026. The busiest year on record is 2018, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 1 |
| 2009 | 5 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 5 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 8 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253367 | EliA CTD 13 Screen | LLL | Substantially Equivalent | |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed | DHB | Substantially Equivalent | |
| K210902 | EliA Ro52, EliA Ro60 | LKJ | Substantially Equivalent | |
| K202541 | EliA RNA Pol III | NYO | Substantially Equivalent | |
| K202540 | EliA Rib-P | MQA | Substantially Equivalent | |
| K202067 | EliA SmDP-S | LKP | Substantially Equivalent | |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | DHB | Substantially Equivalent | |
| K190710 | EliA SymphonyS Immunoassay | LLL | Substantially Equivalent | |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | DHB | Substantially Equivalent | |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | MVM | Substantially Equivalent | |
| K183007 | EliA SmDP Immunoassay | LKP | Substantially Equivalent | |
| K182747 | EliA RF IgM Immunoassay | DHR | Substantially Equivalent | |
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | LJM | Substantially Equivalent | |
| K181556 | EliA M2 Immunoassay | DBM | Substantially Equivalent | |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | MSV | Substantially Equivalent | |
| K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | DHB | Substantially Equivalent | |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | MOB | Substantially Equivalent | |
| K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | OYL | Substantially Equivalent | |
| K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | DHB | Substantially Equivalent | |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls | DGC | Substantially Equivalent | |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | JZO | Substantially Equivalent | |
| K150597 | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite | DHB | Substantially Equivalent | |
| K151029 | Phadia Prime | DHB | Substantially Equivalent | |
| K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut | DHB | Substantially Equivalent | |
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | DBM | Substantially Equivalent | |
| K140493 | ELIA SCL-70S IMMUNOASSAY | LJM | Substantially Equivalent | |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | MOB | Substantially Equivalent | |
| K132631 | EIA SMDP IMMUNOASSAY | LKP | Substantially Equivalent | |
| K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH | DGC | Substantially Equivalent | |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | MID | Substantially Equivalent | |
| K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | DHB | Substantially Equivalent | |
| K131738 | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H | DHB | Substantially Equivalent | |
| K123275 | IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM | DHB | Substantially Equivalent | |
| K121156 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | DHB | Substantially Equivalent | |
| K113841 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE | DHB | Substantially Equivalent | |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | MSV | Substantially Equivalent | |
| DEN120001 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE | OYL | Unknown | |
| K111919 | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS | DHB | Substantially Equivalent | |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | DHR | Substantially Equivalent | |
| K101251 | IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN | DHB | Substantially Equivalent | |
| K100999 | IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 | DHB | Substantially Equivalent | |
| K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 | MST | Substantially Equivalent | |
| K091845 | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | MID | Substantially Equivalent | |
| K092978 | IMMUNOCAP RAPID READER, MODEL 12-3600-10 | DHB | Substantially Equivalent | |
| K092050 | IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 | DHB | Substantially Equivalent | |
| K083117 | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 | LKO | Substantially Equivalent | |
| K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | LKJ | Substantially Equivalent | |
| K081830 | IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 | DHB | Substantially Equivalent | |
| K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | LJM | Substantially Equivalent | |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | LLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3039353646 | 3039353646 | PHADIA AB | Almungevagen 35, Uppsala 754 54 SE | 2026 | and 9 more, listed in full below |
| 9610566 | 3002807876 | PHADIA AB | RAPSGATAN 7P, UPPSALA SE-751 37 SE | 2026 | and 20 more, listed in full below |
| 9680745 | 3005774014 | PHADIA GMBH | MUNZINGER STRASSE 7, FREIBURG Baden-Wurttemberg D-79111 DE | 2026 | and 5 more, listed in full below |
| 3004973408 | 3004973408 | PHADIA US INC. | 4169 COMMERCIAL AVE., Portage, MI 49002 US | 2026 | and 42 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KEMAgent, Clearing
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LSWAnti-Dna Antibody, Antigen And Control
- MQAAnti-Ribosomal P Antibodies
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- MSTAntibodies, Gliadin
- LJNAntibody Igm, If, Epstein-Barr Virus
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GNYAntisera, Fluorescent, Adenovirus 1-33
- LKIAntisera, Fluorescent, Chlamydia Spp.
- GNSAntisera, Hai, Influenza Virus A, B, C
- JRYAntiserum, Fluorescent, Epstein-Barr Virus
- GRAAntiserum, Fluorescent, Mumps Virus
- GREAntiserum, Fluorescent, Rubeola
- GRGAntiserum, Hai, Rubeola
- NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- JQPCalculator/Data Processing Module, For Clinical Use
- NNIContainer, Specimen, Non-Sterile
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- LQGDna-Reagents, Mycoplasma Spp.
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- LLLExtractable Antinuclear Antibody, Antigen And Control
- PPMGeneral Purpose Reagent
- DGCIge, Antigen, Antiserum, Control
- JNLImmunochemical, Thyroglobulin Autoantibody
- LEBMounting Media
- OHQMulti-Analyte Controls Unassayed
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JCCPh Buffer
- LJGQuality Control Slides
- LSRReagent, Borrelia Serological Reagent
- MVUReagents, Specific, Analyte
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JQWStation, Pipetting And Diluting, For Clinical Use
- MIDSystem, Test, Anticardiolipin Immunological
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- OYLTryptase Assay System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0783-2024 | EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic | Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen. | Class II | Open, Classified | |
| Z-2041-2023 | Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002 | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument | Class II | Open, Classified | |
| Z-2040-2023 | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 14553901 | Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument | Class II | Open, Classified | |
| Z-1107-2021 | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01 | Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results). | Class II | Terminated | |
| Z-2397-2019 | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results. | code 7-102 Liquid Sensor Error | Class II | Terminated | |
| Z-1907-2019 | EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000. | Potential for reporting low assay results | Class II | Terminated | |
| Z-1313-2018 | ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. | The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. | Class II | Terminated | |
| Z-1312-2018 | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. | The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. | Class II | Terminated | |
| Z-1276-2018 | 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. | We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU). | Class II | Terminated | |
| Z-0387-2018 | Phadia 1000 Instrument, Article Number 12-3800-01. | The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. | Class II | Terminated | |
| Z-1253-2017 | EliA Sample Diluent, Article number, 83-1023-01 | Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate. | Class II | Terminated | |
| Z-0697-2016 | 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. | All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies. | Class II | Terminated | |
| Z-0947-2015 | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. | During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run. | Class II | Terminated | |
| Z-2285-2012 | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) | Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results. | Class III | Terminated | |
| Z-1055-2012 | ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma. | The firm found this lot of ImmunoCAP Allergen Ri206, American Cockroach does not contain sufficient levels of some cockroach allergens e.g. tropomyosin. Approximately 2% of the positive samples have a risk to fall below the Limit of Quantization (o .1 kUA/L). | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain