--- title: "LumiraDx Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search LumiraDx recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/lumiradx/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # LumiraDx recall records **1** reported ongoing 4 records in this archive. Latest source date Apr 25, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 25, 2023 FDA device enforcement ### [SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB](https://isitonrecall.com/recall/fda-device-z-1970-2023-steripack-sterile-polyester-spun-swabs-25-units-pack-intended-for-sample-collection-in-the-intended/) Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the int...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1970-2023%22) Sep 23, 2022 FDA device enforcement ### [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 testi...](https://isitonrecall.com/recall/fda-device-z-0135-2023-lumiradx-sars-cov-2-antigen-ag-liquid-quality-control-kit-catalog-l016080109002-eua-the-lumiradx-sar/) 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 ... Class III Reported terminated Distribution: US Nationwide distribution. [Official source for LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The Lu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0135-2023%22) Jun 24, 2022 FDA device enforcement ### [LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip](https://isitonrecall.com/recall/fda-device-z-1450-2022-lumiradx-sars-cov-2-antibody-ab-test-strip/) Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. Class II Reported terminated Distribution: Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI. [Official source for LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1450-2022%22) Jun 24, 2022 FDA device enforcement ### [LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control](https://isitonrecall.com/recall/fda-device-z-1451-2022-lumiradx-sars-cov-2-antibody-ab-liquid-quality-control/) Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. Class II Reported terminated Distribution: Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI. [Official source for LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1451-2022%22) ## Reasons in these listed records - Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab - 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 resul... - Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. These examples come from this result page and are not a ranking of every recall reason. ## Checking LumiraDx ### Is there a recall on lumiradx right now? This archive contains 4 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search LumiraDx](https://isitonrecall.com/check/?q=LumiraDx) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)