PlainRecalls

Phadia US Inc

9 recalls on record · Latest: Jul 5, 2023

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Agency notice ledger

Federal filing book Phadia US Inc LIGHT-BOOK · SINGLE-AGENCY

#1,646 of 14,151 · 9 notices · 0.009% archive

  • BOOK 9 notices
  • RANK #1,646 of 14,151
  • SHARE 0.009% archive
  • AGENCY FDA Devices (9)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 5, 2023
  • PHOTO 3Cs Organics LLC

Nearest notice-volume peer: 3Cs Organics LLC (0 notice gap)

Phadia US Inc accounts for about 0.009% of the 104,423-notice archive on 9 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Phadia US Inc's standing among 14,151 recalling firms

Phadia US Inc ranks 1,646th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Phadia US Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

9 1646th of 14151 higher than 12,464 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Phadia US Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Phadia US Inc holds about 0.009% of archive notices alongside 9 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 5, 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

FDA Devices Moderate Jul 5, 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

FDA Devices Moderate Feb 17, 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

FDA Devices Moderate Apr 11, 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 Devices Moderate Apr 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 Devices Moderate Jan 24, 2018

Phadia 1000 Instrument, Article Number 12-3800-01.

FDA Devices Moderate Mar 8, 2017

EliA Sample Diluent, Article number, 83-1023-01

FDA Devices Moderate Jan 21, 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.

FDA Devices Low Sep 5, 2012

PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)

Phadia US Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Phadia US Inc?
PlainRecalls indexes 9 distinct federal recall events naming Phadia US Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Phadia US Inc sit among other recalling firms?
Phadia US Inc ranks #1,646 of 14,151 by distinct recall-event count among 14,151 firms in this archive (88th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Phadia US Inc's notices?
FDA Devices accounts for 9 of this firm's 9 indexed notices.
What product category dominates Phadia US Inc's filing book?
Filings for Phadia US Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Phadia US Inc: 9 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Phadia US Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026