Lower riskMedical device recall · FDA · Published June 24, 2022
LumiraDx SARS-CoV-2 Antibody Test Recall: Quality Control Modification
LumiraDx recalls SARS-CoV-2 Antibody tests with a quality control modification made outside approved EUA. Affected units have specific lot numbers and catalog codes.
“LumiraDx SARS-CoV-2 Antibody Test Recall: Quality Control Modification.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60424-lumiradx-sars-cov-2-antibody-test-recall-quality-control-modification. Based on FDA recall #Z-1451-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1451-2022%22&limit=1).
LumiraDx voluntarily recalled its LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control due to unauthorized modifications made outside the scope of the approved EUA, the FDA said on June 24, 2022. The recall involves 99 units distributed in 13 states.
How to tell if you have it
Brand: LumiraDx
Product: LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Catalog No.: L017080109002
Lot No.: 2002201428 (Exp. 01-Sept-2022)
The hazard
The hazard stems from a modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved Emergency Use Authorization, according to the FDA.
Context
GovInfoNow's records show LumiraDx has had four other recalls since Jan. 11, 2021. Other recent recalls of similar products include GET TESTED Urinary Tract Infection Test Recall (Nov. 3, 2025), Syphilis Test Recall (Nov. 3, 2025), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check for the catalog number L017080109002 and lot number 2002201428 (expires Sept 1, 2022). No UDI codes are present on these units.
Brand
LumiraDx
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip; No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022).
635 units
Z-1451-2022
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control; No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).
99 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the catalog number L017080109002 and lot number 2002201428 on the test kit.
Where it went and when
Where it was distributed
Distributed in 13 states.
Listed by the agency
Not listed
FDA distribution: “Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Florida, Maryland, Massachusetts, Nevada, New Jersey, New York, North Carolina, Oklahoma, Tennessee, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1451-2022 (June 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1451-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.