Magellan recalls LeadCare Plus Blood Lead Test Kit (Catalog 82-0004) due to false positive lead results from third-party micro-collection devices, causing unnecessary testing. All units affected.
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 recalls its LeadCare Plus Blood Lead Test Kit because using certain third-party micro-collection devices can cause false high lead results. This may lead to unnecessary follow-up tests and delays in accurate diagnosis.
The test kit can produce false high lead results when paired with specific third-party micro-collection devices. This may cause unnecessary additional testing and delays in identifying true lead levels.
Parents or caregivers using the LeadCare Plus kit for home blood lead testing are most affected. The recall applies to all units sold with the specific catalog number.
Check for the catalog number 82-0004 on the LeadCare Plus Blood Lead Test Kit. All units sold with this catalog number are affected, including all lots and sublots.
Look for the catalog number 82-0004 on the LeadCare Plus Blood Lead Test Kit to confirm if it is affected.
No, the recall is for false positive results that may cause unnecessary testing, not a direct health risk.
Check for the catalog number 82-0004 on the kit. All units with this number are affected, including all lots and sublots.
The official recall does not specify a remedy, so you can continue using the kit but be aware of potential false results with certain devices.
We’ve drafted a message you can send Magellan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1894-2026 — Magellan Diagnostics Magellan Diagnostics Hello, I own a Magellan Diagnostics that is covered by recall Z-1894-2026 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.
