Lower riskMedical device recall · FDA · Published August 8, 2018
Magellan LeadCare II Blood Lead Test Kit: Calibration Button Defect Causes False High
Magellan recalls LeadCare II Blood Lead Test Kit (lot 1808M) due to calibration button defect causing false high lead levels. This affects professional blood lead testing devices.
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
Take action
Contact the company
📍Recalling firmMagellan Diagnostics, Inc.101 Billerica Ave Bldg 4 · North Billerica, MA 01862-1271
“Magellan LeadCare II Blood Lead Test Kit: Calibration Button Defect Causes False High.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70180-magellan-leadcare-ii-blood-lead-test-kit-calibration-button-defect. Based on FDA recall #Z-0285-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0285-2019%22&limit=1).
The FDA announced on August 8, 2018, that Magellan Diagnostics, Inc. is recalling Magellan LeadCare II Blood Lead Test Kits due to a defect in the calibration button for lot 1808M. This defect causes quality control values and patient testing results to display as HIGH (>65 µg/dL).
How to tell if you have it
Brand: Magellan
Product: Magellan LeadCare II Blood Lead Test Kit
Catalog Number: 70-6762
Primary DI No: 00850355006000
Lot codes: 1808M, 1808M-01 through 1808M-09
Expiration Date: November 10, 2019
Units affected: 1,465 kits
The hazard
The defect with the calibration button for lot 1808M causes Level 1 and Level 2 Quality Control values to generate results of HIGH (>65 µg/dL). Results for patient testing with this lot will also be displayed as HIGH.
Context
GovInfoNow's records show Magellan Diagnostics, Inc. has 5 other recalls on record since January 9, 2018. Other recent recalls of similar products include Boston Scientific INFINION CX Lead Kits Recall (June 17, 2026), Siemens Atellica CH A1c_E Hemoglobin Test May Give Low Results (February 23, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026).
How to tell if you have this one
Check for the product catalog number 70-6762 and lot numbers 1808M-01 through 1808M-09. The test kit is for professional use only and expires November 10, 2019.
Brand
Magellan
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number on the test kit packaging; affected lots are 1808M-01 to 1808M-09.
Verify Test Results
If you have the affected lot, ensure the test results are not displayed as HIGH before proceeding with any medical decisions.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.” 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 terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0285-2019 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0285-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.