Phadia US, Inc.
Medical device manufacturer in Portage, MI.
21510(k) clearances
0PMA approvals
10recalls
Device types
- DHB System, Test, Radioallergosorbent (Rast)… 4
- MVM Autoantibodies, Endomysial(Tissue… 2
- MST Antibodies, Gliadin 2
- MID System, Test, Anticardiolipin Immunological 2
- JNL Immunochemical, Thyroglobulin Autoantibody 1
- LSW Anti-Dna Antibody, Antigen And Control 1
- LLL Extractable Antinuclear Antibody, Antigen… 1
- LJM Antinuclear Antibody (Enzyme-Labeled)… 1
- LKJ Antinuclear Antibody, Antigen, Control 1
- LKO Anti-Rnp Antibody, Antigen And Control 1
- DHR System, Test, Rheumatoid Factor 1
- MSV System,Test,Antibodies,B2 - Glycoprotein I… 1
- LKP Anti-Sm Antibody, Antigen And Control 1
- MOB Test System, Antineutrophil Cytoplasmic… 1
- DBM Antimitochondrial Antibody, Indirect… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | 02/13/2015SE |
| K140225 | Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional | 10/27/2014SE |
| K132631 | Eia SMDP ImmunoassayLKP · Traditional | 08/29/2014SE |
| K131821 | Elia(Tm) Cardiolipin Iga ImmunoassayMID · Traditional | 12/23/2013SE |
| K122197 | Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…DHB · Traditional | 08/28/2013SE |
| K113841 | Immunocap Allergen Components BundleDHB · Traditional | 09/13/2012SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | 06/22/2012SE |
| K111919 | Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsDHB · Traditional | 12/22/2011SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | 09/30/2011SE |
| K093459 | Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…MST · Traditional | 08/13/2010SE |
| K091845 | Cardiolipin Autoantibody Immunological Test SystemMID · Traditional | 06/07/2010SE |
| K092978 | Immunocap Rapid Reader, Model 12-3600-10DHB · Traditional | 01/19/2010SE |
| K083117 | Elia RNP70 Immunoassay, Elia SCI-70 Immunoassay and Elia JO-1 Immunoassay, Models…LKO · Traditional | 05/28/2009SE |
| K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia Ro ImmunoassayLKJ · Traditional | 04/10/2009SE |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | 03/13/2009SE |
| K072149 | Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01LLL · Traditional | 01/15/2008SE |
| K072393 | Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01LSW · Traditional | 12/07/2007SE |
| K072661 | Immunocap Thyrlobulin ImmunocapJNL · Special | 11/20/2007SE |
| K063775 | Elia Gliadin Iga, Igg and Celiac ControlMST · Traditional | 03/14/2007SE |
| K062787 | Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01MVM · Traditional | 12/29/2006SE |
| K062583 | Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01MVM · Traditional | 12/26/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2041-2023 Class II | Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG…Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to… | 05/01/2023Open, Classified |
| Z-2040-2023 Class II | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA…Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to… | 05/01/2023Open, Classified |
| Z-1107-2021 Class II | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of…Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially… | 12/14/2020Terminated |
| Z-1313-2018 Class II | ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific…The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. | 12/18/2017Terminated |
| Z-1312-2018 Class II | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE…The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. | 12/18/2017Terminated |
| Z-0387-2018 Class II | 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… | 07/05/2017Terminated |
| Z-1253-2017 Class II | EliA Sample Diluent, Article number, 83-1023-01Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia… | 01/30/2017Terminated |
| Z-0947-2015 Class II | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All…During an investigation of instrument logs it was determined that In specific circumstances involving… | 11/20/2014Terminated |
| Z-2285-2012 Class III | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM…Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004… | 08/02/2012Terminated |
| Z-1055-2012 | ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte…The firm found this lot of ImmunoCAP Allergen Ri206, American Cockroach does not contain sufficient levels… | 01/03/2012Terminated |