Magellan Diagnostics, Inc. Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 Recall
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Brand
Magellan Diagnostics, Inc.
Lot Codes / Batch Numbers
Kit lots: 1309BU, 1310AU, 1312BU, 1404AU, 1408BU
Products Sold
Kit lots: 1309BU,1310AU,1312BU,1404AU,1408BU
Magellan Diagnostics, Inc. is recalling Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 due to LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026