Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits due to false positive results when using third-party micro-collection devices, potentially causing unnecessary testing and delays.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits (including 5X and 9X versions) because they can produce false high lead levels when used with certain third-party micro-collection devices. This may lead to unnecessary follow-up tests and delays in getting accurate results.
The test kits can give false high lead readings when used with specific third-party micro-collection devices. This happens because the devices may interfere with the test's accuracy, leading to unnecessary follow-up testing and potential delays in identifying true lead levels.
People who use the LeadCare II Blood Lead Test Kits with third-party micro-collection devices for home lead testing are affected. Those who have already used these kits with such devices may be at risk of false positive results.
Check for the LeadCare II Blood Lead Test Kit (1, 5X, or 9X versions) with catalog numbers 70-6762, 70-6762RUO, 70-8404, or 70-9000. All lots and sublots are affected.
If you used the test kit with a third-party micro-collection device, look for unexpectedly high lead results.
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices with the LeadCare II Blood Lead Test Kits.
The recall does not require immediate action, but if you used the kit with a third-party micro-collection device and got high results, check for false positives.
Yes, all versions (1, 5X, and 9X) with catalog numbers 70-6762, 70-6762RUO, 70-8404, and 70-9000 are affected.
We’ve drafted a message you can send Magellan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1893-2026 — Magellan Diagnostics Magellan Diagnostics Hello, I own a Magellan Diagnostics that is covered by recall Z-1893-2026 from Magellan Diagnostics. 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.
