Magellan Diagnostics recalls LeadCare Ultra Blood Lead Test Kit (Catalog 70-8098) due to false positive lead results from third-party micro-collection devices, 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 its LeadCare Ultra Blood Lead Test Kit because using certain third-party micro-collection devices can cause false high lead readings. This may lead to unnecessary follow-up tests and delays in identifying actual lead levels.
The test kit can produce false high lead results when paired with specific third-party micro-collection devices. This leads to unnecessary additional testing and potential delays in accurate lead level assessment, which could affect health decisions.
Anyone using the LeadCare Ultra Blood Lead Test Kit with third-party micro-collection devices for blood lead testing. Children and individuals with lead exposure concerns are at higher risk due to potential false positives.
Check for the LeadCare Ultra Blood Lead Test Kit with Catalog Number 70-8098. The kit includes sensors, treatment reagent tubes, calibration button, and lead control levels. All lots and sublots are affected.
Ensure you are using only Magellan's official micro-collection devices with the LeadCare Ultra kit to avoid false positive results.
No, the recall is for false positive results that may cause unnecessary testing, not actual health risks.
The recalled kit has Catalog Number 70-8098 and includes sensors, treatment reagent tubes, calibration button, and lead control levels. All lots and sublots are affected.
The recall does not provide a fix; users must ensure they use only Magellan's official micro-collection devices to prevent false positives.
We’ve drafted a message you can send Magellan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1895-2026 — Magellan Diagnostics Magellan Diagnostics Hello, I own a Magellan Diagnostics that is covered by recall Z-1895-2026 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.
