--- title: "QUIDELORTHO Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search QUIDELORTHO recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/quidelortho/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # QUIDELORTHO recall records **2** reported ongoing 2 records in this archive. Latest source date Apr 9, 2024. 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 9, 2024 FDA device enforcement ### [VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product...](https://isitonrecall.com/recall/fda-device-z-1818-2024-vitros-immunodiagnostic-products-free-t3-reagent-pack-ivd-is-for-the-quantitative-measurement-of-fre/) T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, ... [Official source for VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1818-2024%22) Apr 9, 2024 FDA device enforcement ### [VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and...](https://isitonrecall.com/recall/fda-device-z-1819-2024-vitros-immunodiagnostic-products-free-t3-calibrators-ivd-are-for-use-with-free-t3-reagent-pack-for-t/) Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, ... [Official source for VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack fo...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1819-2024%22) ## Reasons in these listed records - T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of... - Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of... These examples come from this result page and are not a ranking of every recall reason. ## Checking QUIDELORTHO ### Is there a recall on quidelortho right now? This archive contains 2 records, including 2 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 QUIDELORTHO](https://isitonrecall.com/check/?q=QUIDELORTHO) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)