16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
FDA Recall
Terminated
·Phadia US Inc·Product code LSW·December 14, 2020
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.
FDA Recall
Terminated
·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHR·May 10, 2019
EliA Sample Diluent, Article number, 83-1023-01
FDA Recall
Terminated
·Phadia US Inc·Product code NHX·January 30, 2017
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
FDA Recall
Terminated
·Phadia US Inc·Product code MID·August 2, 2012
Phadia 1000 Instrument, Article Number 12-3800-01.
FDA Recall
Terminated
·Phadia US Inc·Product code DHB·July 5, 2017
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.
FDA Recall
Terminated
·Phadia US Inc·Product code DHB·December 18, 2017
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.
FDA Recall
Terminated
·Phadia US Inc·Product code DHB·December 18, 2017
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.
FDA Recall
Terminated
·Phadia US Inc·Product code DHB·November 20, 2014
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.
FDA Recall
Terminated
·Phadia US Inc·Product code MVU·January 3, 2012
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.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·January 21, 2015
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
FDA Enforcement
Class III
·Terminated·Phadia US Inc·September 5, 2012
EliA Sample Diluent, Article number, 83-1023-01
FDA Enforcement
Class II
·Terminated·Phadia US Inc·March 8, 2017
Phadia 1000 Instrument, Article Number 12-3800-01.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·January 24, 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.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·April 11, 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.
FDA Enforcement
Class II
·Terminated·Phadia US Inc·April 11, 2018
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
FDA Enforcement
Class II
·Terminated·Phadia US Inc·February 17, 2021