--- title: "Helena Laboratories, Corp. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Helena Laboratories, Corp. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/helena-laboratories-corp/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Helena Laboratories, Corp. recall records **2** reported ongoing 2 records in this archive. Latest source date May 2, 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 May 2, 2023 FDA device enforcement ### [Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics](https://isitonrecall.com/recall/fda-device-z-1975-2023-serrated-blade-applicator-kit-12-sample-ref-552687-for-use-with-the-spife-nexus-system-contents-30-b/) Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result. Class II Reported ongoing Distribution: Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand. [Official source for Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Cont...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1975-2023%22) Apr 6, 2022 FDA device enforcement ### [V8 Immunodisplacement Kit REF 1803](https://isitonrecall.com/recall/fda-device-z-1244-2022-v8-immunodisplacement-kit-ref-1803/) Due to microbial growth causing interference with interpretation. Class II Reported ongoing Distribution: U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam, [Official source for V8 Immunodisplacement Kit REF 1803](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1244-2022%22) ## Reasons in these listed records - Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result. - Due to microbial growth causing interference with interpretation. These examples come from this result page and are not a ranking of every recall reason. ## Checking Helena Laboratories, Corp. ### Is there a recall on helena laboratories, corp. 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 Helena Laboratories, Corp.](https://isitonrecall.com/check/?q=Helena%20Laboratories%2C%20Corp.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)