Lower riskMedical device recall · FDA · Published February 23, 2024
Magellan LeadCare II Blood Lead Test Kit: Mislabeling May Cause Inaccurate Results
Magellan Diagnostics recalls LeadCare II Blood Lead Test Kit with mislabeled calibration buttons that may cause inaccurate lead test results. Affected lots include 2333M and variants. Consumers should check their kit's lot number and contact Magellan for guidance.
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.
Take action
Contact the company
📍Recalling firmMagellan Diagnostics, Inc.101 Billerica Ave Bldg 4 · North Billerica, MA 01862-1271
✎ GovInfoNow plain-language explainer
Magellan Diagnostics is recalling its LeadCare II Blood Lead Test Kit because calibration buttons were mislabeled, which could lead to inaccurate blood lead test results. This affects kits with specific lot numbers and may cause delayed or incorrect readings if used without proper calibration. Read more at govinfonow.com/recall/56091-magellan-leadcare-ii-blood-lead-test-kit-mislabeling-may-cause.
“Magellan LeadCare II Blood Lead Test Kit: Mislabeling May Cause Inaccurate Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56091-magellan-leadcare-ii-blood-lead-test-kit-mislabeling-may-cause. Based on FDA recall #Z-0584-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0584-2026%22&limit=1).
The FDA announced on Feb. 23, 2024, that Magellan Diagnostics, Inc. is recalling The LeadCare II Blood Lead Test System due to mislabeled calibration buttons that may cause erroneous lead results. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Magellan Diagnostics
Product: The LeadCare II Blood Lead Test Kit
Catalog Number: 70-6762
UPC: 00850355006000
Lot Numbers: 2333M, 2333M-01 through 2333M-11
The hazard
Calibration Buttons used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of these mislabeled calibration buttons with Lot #2333 can lead to delayed or erroneous high or low results.
Context
GovInfoNow's records show Magellan Diagnostics, Inc. has five other recalls on record since Jan. 9, 2018. Other recent recalls of similar products include GEM Premier 5000 Blood Analyzer May Assign Results to Wrong Patient ID (May 8, 2026), GEM Premier 5000/7000 Blood Analyzers Risk Patient ID Errors with Bar Code Readers (May 8, 2026), and GEM Premier 5000 Blood Analyzer: Risk of Wrong Patient ID Assignment (May 8, 2026).
How to tell if you have this one
Check the calibration button's lot number on the kit. Affected kits have lot numbers starting with 2333M, including variants like 2333M-01 through 2333M-11.
Brand
Magellan Diagnostics
Product
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number on the calibration button, which should be 2333M or a variant like 2333M-01 through 2333M-11.
Contact Magellan
Reach out to Magellan Diagnostics for further guidance on whether your kit is affected and what to do next.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 21 months 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-0584-2026 (February 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0584-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.