Lower riskMedical device recall · FDA · Published March 13, 2026
Magellan LeadCare Plus Blood Lead Test Kit: False Positive Results Risk
Magellan recalls LeadCare Plus Blood Lead Test Kit (Catalog 82-0004) due to false positive lead results from third-party micro-collection devices, causing unnecessary testing. All units affected.
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.
Take action
Contact the company
📍Recalling firmMagellan Diagnostics, Inc.101 Billerica Ave Bldg 4 · North Billerica, MA 01862-1271
“Magellan LeadCare Plus Blood Lead Test Kit: False Positive Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49728-magellan-leadcare-plus-blood-lead-test-kit-false-positive-results. Based on FDA recall #Z-1894-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1894-2026%22&limit=1).
The FDA announced on March 13, 2026, that Magellan Diagnostics is recalling the LeadCare Plus Blood Lead Test Kit (Catalog Number 82-0004) due to a hazard of false positive results. The recall covers all lots and sublots distributed worldwide.
How to tell if you have it
Brand: Magellan Diagnostics
Product: LeadCare Plus Blood Lead Test Kit
Catalog Number: 82-0004
UDI-DI: 00850355006031
Distribution: Worldwide
The hazard
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.
Context
GovInfoNow's records show Magellan Diagnostics, Inc. has 5 other recalls on record since 2018-01-09. Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05), Diagnostica Stago Asserachrom HPIA Kit Recall (2025-12-15), and Boston Scientific INFINION CX Lead Kits Recall (2026-06-17).
How to tell if you have this one
Check for the catalog number 82-0004 on the LeadCare Plus Blood Lead Test Kit. All units sold with this catalog number are affected, including all lots and sublots.
Brand
Magellan Diagnostics
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
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 Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa, South Korea, Spain, UAE, Uruguay, Vietnam.
Recall number
Product, codes & lots
Quantity
Z-1893-2026
(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) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer Droppers (50 @) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL); Catalog Number(s): (1) 70-6762, (2) 70-6762RUO; UDI-DI: 00850355006000; ALL lots and ALL sublots; Catalog Number(s): (3) 70-8404; UDI-DI: 00850355006086; ALL lots and ALL sublots; Catalog Number(s): (4) 70-9000; UDI-DI: 00850355006093; ALL lots and ALL sublots;
197893
Z-1894-2026
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) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL); Catalog Number: 82-0004; UDI-DI: 00850355006031; ALL lots and ALL sublots;
136
Z-1895-2026
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) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL); Catalog Number: 70-8098; UDI-DI: 00850355006024; ALL lots and ALL sublots;
284
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for the catalog number 82-0004 on the LeadCare Plus Blood Lead Test Kit to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1894-2026 (March 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1894-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.