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.
Magellan is recalling its LeadCare II Blood Lead Test Kit for specific lots because a calibration button defect causes false high lead level results. This could lead to incorrect health assessments if used for professional blood lead testing.
The calibration button defect causes the test kit to display lead levels as HIGH (>65 μg/dL) when the actual level is lower. This leads to false high results that could mislead healthcare providers about a patient's lead exposure.
Healthcare professionals using the LeadCare II Blood Lead Test Kit for professional blood lead testing are affected. Those with the specific lot numbers (1808M-01 to 1808M-09) are most at risk.
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.
Look for the lot number on the test kit packaging; affected lots are 1808M-01 to 1808M-09.
If you have the affected lot, ensure the test results are not displayed as HIGH before proceeding with any medical decisions.
The affected lot numbers are 1808M-01 through 1808M-09.
The calibration button defect causes the test kit to display lead levels as HIGH (>65 μg/dL) when the actual level is lower, leading to false high results.
The recall record does not specify a remedy.
We’ve drafted a message you can send Magellan to request your refund or repair — edit it as you like.
Subject: Recall Z-0285-2019 — Magellan Magellan Hello, I own a Magellan that is covered by recall Z-0285-2019 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.
