Magellan Diagnostics recalls LeadCare II Blood Lead Test Kit with mislabeled calibration buttons that may cause inaccurate lead test results. Affected lots include 2333M and variants. Consumers should check their kit's lot number and contact Magellan for guidance.
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
Magellan Diagnostics is recalling its LeadCare II Blood Lead Test Kit because calibration buttons were mislabeled, which could lead to inaccurate blood lead test results. This affects kits with specific lot numbers and may cause delayed or incorrect readings if used without proper calibration.
The calibration button was incorrectly labeled as Lot 2333M when it should be Lot 2323M. Using this mislabeled button can cause the test to give delayed or incorrect high or low lead levels, potentially leading to wrong health decisions.
People who own or use the LeadCare II Blood Lead Test Kit with lot numbers 2333M and variants are affected. Those testing for lead exposure in blood may be at risk of inaccurate results.
Check the calibration button's lot number on the kit. Affected kits have lot numbers starting with 2333M, including variants like 2333M-01 through 2333M-11.
Look for the lot number on the calibration button, which should be 2333M or a variant like 2333M-01 through 2333M-11.
Reach out to Magellan Diagnostics for further guidance on whether your kit is affected and what to do next.
The affected lot numbers are 2333M and variants 2333M-01 through 2333M-11.
Yes, if your kit's calibration button has a different lot number than the affected ones, it should be safe to use.
Check the calibration button's lot number on the kit. If it shows 2333M or a variant like 2333M-01 through 2333M-11, it's 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-0584-2026 — Magellan Diagnostics Magellan Diagnostics Hello, I own a Magellan Diagnostics that is covered by recall Z-0584-2026 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.
