Magellan recalls LeadCare Ultra Blood Lead Test Kit (Catalog 70-8098) 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 Ultra Blood Lead Test Kit (Catalog 70-8098) because control tests may give low results, leading to inaccurate blood lead level measurements. This could cause health risks if patients are misinformed about lead exposure.
The test kit's control tests may produce low results, causing the device to underestimate blood lead levels. This means patients might receive false reassurance about lead exposure when actual levels are higher than reported.
People who use the LeadCare Ultra Blood Lead Test Kit for blood lead testing are affected. Those with lead exposure concerns or medical conditions requiring accurate lead levels are at higher risk.
Check for Catalog Number 70-8098 on the kit. Units were sold with Lot Numbers 2011MU to 25MAR22, and later expansions 2104MU to 25AUG22 and 2108MU to 31MAR22.
Look for Catalog Number 70-8098 on the test kit packaging.
Magellan has received reports that control tests may generate low results, potentially underestimating blood lead levels in patient samples.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected kit.
Check for Catalog Number 70-8098 and Lot Numbers 2011MU-25MAR22, 2104MU-25AUG22, or 2108MU-31MAR22.
We’ve drafted a message you can send Magellan to request your refund or repair — edit it as you like.
Subject: Recall Z-1954-2021 — Magellan Magellan Hello, I own a Magellan that is covered by recall Z-1954-2021 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.
