PlainRecalls

LumiraDx

Compiled from official public sources by the publisher.

6 recalls on record · Latest: Jun 21, 2023

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Agency notice ledger

Federal filing book LumiraDx LIGHT-BOOK · SINGLE-AGENCY

#2,212 of 14,151 · 6 notices · 0.006% archive

  • BOOK 6 notices
  • RANK #2,212 of 14,151
  • SHARE 0.006% archive
  • AGENCY FDA Devices (6)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 21, 2023
  • PHOTO 1908 Brands

Nearest notice-volume peer: 1908 Brands (0 notice gap)

LumiraDx accounts for about 0.006% of the 104,423-notice archive on 6 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 →

LumiraDx's standing among 14,151 recalling firms

LumiraDx ranks 2,212th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

LumiraDx vs all firms by recall-notice count

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

6 2212th of 14151 higher than 11,804 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

LumiraDx in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows LumiraDx holds about 0.006% of archive notices alongside 6 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 21, 2023

SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
FDA Devices Low Nov 2, 2022

LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Devices Moderate Jul 27, 2022

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Devices Moderate Jul 27, 2022

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
FDA Devices Moderate Apr 7, 2021

Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
FDA Devices Moderate Feb 24, 2021

LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.

LumiraDx 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 (6 here).

1908 Brands 6 Abbott Molecular 6 Accriva Diagnostics, Inc. 6 Advance Medical Designs, Inc. 6 Agave Dream 6

Similar medical devices volume

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

Abbott Molecular 6 Accriva Diagnostics, Inc. 6 Advance Medical Designs, Inc. 6 American Medical Systems, Inc. 6

Frequently Asked Questions

How many federal recall notices name LumiraDx? ▼
PlainRecalls indexes 6 distinct federal recall events naming LumiraDx, 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 LumiraDx sit among other recalling firms? ▼
LumiraDx ranks #2,212 of 14,151 by distinct recall-event count among 14,151 firms in this archive (83rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of LumiraDx's notices? ▼
FDA Devices accounts for 6 of this firm's 6 indexed notices.
What product category dominates LumiraDx's filing book? ▼
Filings for LumiraDx 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.
LumiraDx: 6 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 LumiraDx; individual notices remain authoritative on each linked recall page.

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