Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits with certain lot numbers due to potential leaking or evaporation of reagents, which could cause false positive results for lead levels.
During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits that may have defective plastic caps causing leaks or evaporation of reagents. This could lead to false positive results for lead levels in blood tests, which might incorrectly indicate high lead levels when they are not present.
The test kit uses plastic caps that may not seal properly, allowing HCl to leak out or the reagent to evaporate. This can change the reagent volume and ratios, leading to false high lead results in blood tests.
People who own or use the LeadCare II Blood Lead Test Kit with the listed lot numbers are affected. Those testing for lead in blood through this kit are most at risk of receiving inaccurate results.
Check the lot numbers on the kit: 2231, 2231-10, 2303M-11 through 2320M-06, and 7308M. The kit is for in vitro diagnostic use only and measures lead in capillary whole blood.
Look for lot numbers listed in the recall: 2231, 2231-10, 2303M-11 through 2320M-06, and 7308M.
The recall is due to a small percentage of plastic caps not meeting dimensional requirements, which may cause leaks or evaporation of reagents, potentially leading to false positive results for lead levels.
Using the kit with defective caps could result in inaccurate blood lead test results, such as a false positive indicating higher lead levels than actually present.
Check the lot numbers on the kit: 2231, 2231-10, 2303M-11 through 2320M-06, and 7308M. The kit is for in vitro diagnostic use only and measures lead in capillary whole blood.
We’ve drafted a message you can send Magellan Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0219-2024 — Magellan Diagnostics Magellan Diagnostics Hello, I own a Magellan Diagnostics that is covered by recall Z-0219-2024 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.
