PlainRecalls

Abbott Ireland Diagnostics Division

Compiled from official public sources by the publisher.

12 recalls on record · Latest: Aug 14, 2019

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Agency notice ledger

Federal filing book Abbott Ireland Diagnostics… LIGHT-BOOK · SINGLE-AGENCY

#1,227 of 14,151 · 12 notices · 0.011% archive

  • BOOK 12 notices
  • RANK #1,227 of 14,151
  • SHARE 0.011% archive
  • AGENCY FDA Devices (12)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 14, 2019
  • PHOTO 2k Innovations Inc.

Nearest notice-volume peer: 2k Innovations Inc. (0 notice gap)

Abbott Ireland Diagnostics Division accounts for about 0.011% of the 104,423-notice archive on 12 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 →

Abbott Ireland Diagnostics…'s standing among 14,151 recalling firms

Abbott Ireland Diagnostics Division ranks 1,227th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Abbott Ireland Diagnostics… vs all firms by recall-notice count

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

12 1227th of 14151 higher than 12,841 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

Abbott Ireland Diagnostics… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Abbott Ireland Diagnostics Division holds about 0.011% of archive notices alongside 12 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 14, 2019

Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
FDA Devices Moderate May 22, 2019

Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
FDA Devices Moderate May 22, 2019

Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
FDA Devices Moderate Feb 13, 2019

ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
FDA Devices Moderate Feb 13, 2019

ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
FDA Devices Moderate Jan 2, 2019

Alinity i Progesterone Reagent Kit, List Number 08P3620
FDA Devices Moderate Jan 2, 2019

Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Devices Moderate Jan 2, 2019

Alinity i Estradiol Reagent Kit, List Number 07P5020
FDA Devices Moderate Jan 2, 2019

Alinity i Free T4 Reagent Kit, List Number 07P7030
FDA Devices Moderate Jan 2, 2019

Alinity i TSH Reagent Kit, List Number 07P4830
FDA Devices Moderate Jan 2, 2019

Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
FDA Devices Moderate Dec 3, 2014

ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle

Abbott Ireland Diagnostics… holds a measurable archive slice

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

Similar recall count

Nearest multi-notice firms by distinct-event totals (12 here — thin-book).

2k Innovations Inc. 12 3fish Inc. 12 Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. 12 Agfa Healthcare Corp. 12 Amgen, Inc. 12

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

2k Innovations Inc. 12 Agfa Healthcare Corp. 12 Boston Scientific 12 Cepheid 12

Frequently Asked Questions

How many federal recall notices name Abbott Ireland Diagnostics…? ▼
PlainRecalls indexes 12 distinct federal recall events naming Abbott Ireland Diagnostics Division, 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 Abbott Ireland Diagnostics… sit among other recalling firms? ▼
Abbott Ireland Diagnostics Division ranks #1,227 of 14,151 by distinct recall-event count among 14,151 firms in this archive (91st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Abbott Ireland Diagnostics…'s notices? ▼
FDA Devices accounts for 12 of this firm's 12 indexed notices.
What product category dominates Abbott Ireland Diagnostics…'s filing book? ▼
Filings for Abbott Ireland Diagnostics Division 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.
Abbott Ireland Diagnostics Division: 12 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 Abbott Ireland Diagnostics Division; individual notices remain authoritative on each linked recall page.

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