--- title: "Magellan Diagnostics, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Magellan Diagnostics, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/magellan-diagnostics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Magellan Diagnostics, Inc. recall records **5** reported ongoing 5 records in this archive. Latest source date Mar 13, 2026. 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 Mar 13, 2026 FDA device enforcement ### [(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-...](https://isitonrecall.com/recall/fda-device-z-1893-2026-1-2-leadcare-ii-blood-lead-test-kit-3-leadcare-ii-5x-blood-lead-test-kit-4-leadcare-ii-9x-blood-lea/) Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional ... Class II Reported ongoing Distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong... [Official source for (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1893-2026%22) Mar 13, 2026 FDA device enforcement ### [LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Tre...](https://isitonrecall.com/recall/fda-device-z-1894-2026-leadcare-plus-blood-lead-test-kit-catalog-number-82-0004-the-leadcare-plus-kit-is-provided-with-the/) Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional ... Class II Reported ongoing Distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong... [Official source for LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided w...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1894-2026%22) Mar 13, 2026 FDA device enforcement ### [LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Tr...](https://isitonrecall.com/recall/fda-device-z-1895-2026-leadcare-ultra-blood-lead-test-kit-catalog-number-70-8098-the-leadcare-ultra-kit-is-provided-with-th/) Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional ... Class II Reported ongoing Distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong... [Official source for LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided w...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1895-2026%22) Feb 23, 2024 FDA device enforcement ### [The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following ma...](https://isitonrecall.com/recall/fda-device-z-0584-2026-the-leadcare-ii-blood-lead-test-system-relies-on-electrochemistry-and-a-unique-sensor-to-detect-lead/) Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0584-2026%22) Sep 19, 2023 FDA device enforcement ### [LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.](https://isitonrecall.com/recall/fda-device-z-0219-2024-leadcare-ii-blood-lead-test-kit-for-in-vitro-diagnostic-use-only-the-test-kit-is-for-the-quantitativ/) During an internal audit a small percentage ( Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantit...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0219-2024%22) ## Reasons in these listed records - Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing. - Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results. - During an internal audit a small percentage ( These examples come from this result page and are not a ranking of every recall reason. ## Checking Magellan Diagnostics, Inc. ### Is there a recall on magellan diagnostics, inc. right now? This archive contains 5 records, including 5 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 Magellan Diagnostics, Inc.](https://isitonrecall.com/check/?q=Magellan%20Diagnostics%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)