LumiraDx recalls SARS-CoV-2 Antigen Liquid Quality Control Kits with incorrect vial lot numbers that may prevent proper testing. Affected kits could show error messages and fail to function correctly.
Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
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Contact the company
📍Recalling firmLumiraDx221 Crescent St · Waltham, MA 02453-3475
“LumiraDx SARS-CoV-2 Antigen Kit: Incorrect Product Assignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60028-lumiradx-sars-cov-2-antigen-kit-incorrect-product-assignment-risk. Based on FDA recall #Z-0135-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0135-2023%22&limit=1).
The FDA announced on Sept. 23, 2022, that LumiraDx voluntarily recalled its SARS-CoV-2 Antigen Liquid Quality Control Kit due to incorrect lot number assignments. The error could result in an error message preventing use of the quality control kit. This recall involves 83 kits distributed nationwide.
How to tell if you have it
Brand: LumiraDx
Product: LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit
Catalog #: L016080109002 (EUA)
Batch: 2002204017
Positive Control Vial Lot: 1000 1710 0014 0141
Negative Control Vial Lot: 1000 1720 0014 0142
Expiration Date: 01-Mar-2023
The hazard
The recall involves incorrect assignment of SARS-CoV-2 and Flu A/B lot numbers to the positive and negative vial lot numbers for SARS-CoV-2 Ag Liquid Quality Controls. This misassignment results in an error message that prevents the use of the LQC kit.
Context
GovInfoNow's records show LumiraDx has had four other recalls since Jan. 11, 2021. On April 25, 2023, LumiraDx recalled SteriPack Swabs due to breakage risks, and on June 24, 2022, it recalled SARS-CoV-2 Antibody Test Strips for unapproved modifications. Other recent recalls of similar products include Microbiologics KWIK-STIK Quality Control Kit Recall (Nov. 13, 2025) and Medline Convenience Kits Recall (Jan. 7, 2026).
How to tell if you have this one
Check the vial lot numbers on the kit: Positive Control Vial: 1000 1710 0014 0141 and Negative Control Vial: 1000 1720 0014 0142. The kits were sold with batch number 2002204017 and expire on March 1, 2023.
Brand
LumiraDx
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Numbers
Verify the vial lot numbers on the kit: Positive Control Vial: 1000 1710 0014 0141 and Negative Control Vial: 1000 1720 0014 0142.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0135-2023 (September 23, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0135-2023 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.