PlainRecalls

Iris Diagnostics

Compiled from official public sources by the publisher.

4 recalls on record · Latest: Sep 2, 2015

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Agency notice ledger

Federal filing book Iris Diagnostics LIGHT-BOOK · SINGLE-AGENCY

#2,972 of 14,151 · 4 notices · 0.004% archive

  • BOOK 4 notices
  • RANK #2,972 of 14,151
  • SHARE 0.004% archive
  • AGENCY FDA Devices (4)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 2, 2015
  • PHOTO 1 Epic, LLC

Nearest notice-volume peer: 1 Epic, LLC (0 notice gap)

Iris Diagnostics accounts for about 0.004% of the 104,423-notice archive on 4 distinct filings — a light share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Iris Diagnostics compares to 14,151 recalling firms

Iris Diagnostics ranks 2,972nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Iris Diagnostics vs all firms by recall-notice count

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

4 2972nd of 14151 higher than 10,859 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

Iris Diagnostics in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Iris Diagnostics holds about 0.004% of archive notices alongside 4 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 2, 2015

iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
FDA Devices Moderate Dec 31, 2014

RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
FDA Devices Moderate May 22, 2013

Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Devices Low Aug 8, 2012

IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Iris Diagnostics is a small archive contributor

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 (4 here).

1 Epic, LLC 4 3rd Day Beverages LLC 4 A.p. Deauville, LLC 4 Aaa Pharmaceutical, Inc. 4 Aap Implantate Ag 4

Similar medical devices volume

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

Aap Implantate Ag 4 Ab Sciex, LLC 4 Accelerate Diagnostics Inc 4 Accord Media, LLC 4

Frequently Asked Questions

How many federal recall notices name Iris Diagnostics? ▼
PlainRecalls indexes 4 distinct federal recall events naming Iris Diagnostics, 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 Iris Diagnostics sit among other recalling firms? ▼
Iris Diagnostics ranks #2,972 of 14,151 by distinct recall-event count among 14,151 firms in this archive (77th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Iris Diagnostics's notices? ▼
FDA Devices accounts for 4 of this firm's 4 indexed notices.
What product category dominates Iris Diagnostics's filing book? ▼
Filings for Iris Diagnostics 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.
Iris Diagnostics: 4 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 Iris Diagnostics; individual notices remain authoritative on each linked recall page.

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