Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Thermo Fisher ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Phadia US with 21 510(k) clearances and 9 device recalls. The most recent is a device recall dated May 1, 2023: Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 1, 2023 | Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plClass II · Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA G | Device recalls |
| May 1, 2023 | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quaClass II · Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA G | Device recalls |
| Dec 14, 2020 | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and pClass II · Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false | Device recalls |
| Dec 18, 2017 | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measuremClass II · The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. | Device recalls |
| Dec 18, 2017 | ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measuClass II · The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. | Device recalls |
| Jul 5, 2017 | Phadia 1000 Instrument, Article Number 12-3800-01.Class II · The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay | Device recalls |
| Jan 30, 2017 | EliA Sample Diluent, Article number, 83-1023-01Class II · Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instrume | Device recalls |
| Feb 13, 2015 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250K141375 · DBM | 510(k) clearances |
| Nov 20, 2014 | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); MultClass II · During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a | Device recalls |
| Oct 27, 2014 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POK140225 · MOB | 510(k) clearances |
| Aug 29, 2014 | EIA SMDP IMMUNOASSAYK132631 · LKP | 510(k) clearances |
| Dec 23, 2013 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYK131821 · MID | 510(k) clearances |
| Aug 28, 2013 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESK122197 · DHB | 510(k) clearances |
| Sep 13, 2012 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLEK113841 · DHB | 510(k) clearances |
| Jun 22, 2012 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYK112414 · MSV | 510(k) clearances |
| Feb 15, 2012 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASEDEN120001 · OYL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
