Magellan recalls LeadCare II Blood Lead Test Kit (Catalog 70-6762) due to potential underestimation of blood lead levels from low control test results. Affected units include specific lot numbers from 2012M to 2018M.
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 II Blood Lead Test Kit because control tests may show low results, leading to underestimation of blood lead levels in patient samples. This could result in inaccurate lead level readings, which is important for proper diagnosis and treatment.
The test kit's control tests may generate low results, causing the device to underestimate blood lead levels in patient samples. This could lead to incorrect conclusions about lead exposure, potentially delaying necessary medical care.
People who own or use the LeadCare II Blood Lead Test Kit with the specified lot numbers are affected. Children and individuals with lead exposure concerns are at higher risk due to potential inaccurate test results.
Check the kit's catalog number (70-6762) and lot numbers listed in the recall: 2012M through 2018M with specific expiration dates and sublots.
Verify the catalog number (70-6762) and lot numbers from the list provided in the recall notice.
Magellan has received reports that control tests of the Low-Control or High-Control generated low results, which may cause underestimation of blood lead levels in patient samples.
Affected lot numbers range from 2012M to 2018M with specific expiration dates and sublots listed in the recall notice.
The recall notice does not specify a remedy, so no action is required beyond checking if the kit is affected.
We’ve drafted a message you can send Magellan to request your refund or repair — edit it as you like.
Subject: Recall Z-1952-2021 — Magellan Magellan Hello, I own a Magellan that is covered by recall Z-1952-2021 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.
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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.
