Magellan recalls LeadCare Plus Blood Lead Test Kit (Catalog 82-0004) due to potential underestimation of blood lead levels in patient samples. Affected units sold from 2011 to 2022.
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
Magellan is recalling its LeadCare Plus Blood Lead Test Kit (Catalog Number 82-0004) because control tests may give low results, leading to inaccurate blood lead level measurements. This could cause health risks if lead levels are underestimated in patients.
The test kit's control tests may produce low results, causing blood lead levels to be underestimated. This could lead to incorrect conclusions about lead exposure, potentially missing serious health risks.
People who own or use the LeadCare Plus Blood Lead Test Kit with Catalog Number 82-0004. Those testing for lead in blood, particularly in children or high-risk environments, are most at risk.
Check for Catalog Number 82-0004 on the kit. Units were sold with Lot Numbers 2011MU to 25MAR22, 2104MU to 25AUG22, and 2108MU to 31MAR22.
Look for Catalog Number 82-0004 on the test kit packaging or label.
Magellan has received reports that control tests may generate low results, potentially underestimating blood lead levels in patient samples.
The recall does not specify a remedy, so check the kit's Catalog Number 82-0004 to confirm if it's affected.
Affected kits have Catalog Number 82-0004 with Lot Numbers 2011MU to 25MAR22, 2104MU to 25AUG22, or 2108MU to 31MAR22.
We’ve drafted a message you can send Magellan to request your refund or repair — edit it as you like.
Subject: Recall Z-1953-2021 — Magellan Magellan Hello, I own a Magellan that is covered by recall Z-1953-2021 from Magellan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
