Summary
Magellan Diagnostics, Inc. and the U.S. Food
and Drug Administration (FDA) have issued notifications about the expansion of
Magellan Diagnostics’ recall of LeadCare II, LeadCare Plus, and LeadCare Ultra
Blood Lead Tests, which were distributed from October 27, 2020, to August 19,
2021. Additional LeadCare II product lots, including lots previously reported
to be unaffected, were recalled due to a significant risk of falsely low
results. The use of these devices may cause serious injuries because they might
underestimate blood lead levels. FDA has identified this as a Class I recall,
the most serious type of recall.
The Centers for Disease Control and Prevention
(CDC) is issuing this Health Alert Network (HAN) Health Update to notify
healthcare providers and state and local health departments about the expansion
of the recall notice and to recommend appropriate follow-up actions in the
shortage of LeadCare Lead Tests. This HAN Health Update is an update to HAN Health
Advisory 445: Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low
Results
that CDC issued on July 6, 2021.
Background
Magellan Diagnostics, Inc. is
recalling LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test kits
due to a significant risk of falsely low blood lead level results. FDA has
concerns that the falsely low results may contribute to health risks in special
populations such as young children and pregnant individuals. A pregnant or
lactating individual’s exposure to lead is concerning because it may cause
health problems for the parent and the developing baby. Obtaining falsely low
blood lead level results may lead to patients not receiving appropriate
follow-up assessments, which may result in patient harm, including delayed
puberty, reduced postnatal growth, decreased IQ, and attention and behavior
problems in children.
FDA initially notified CDC on June 24, 2021,
that some Magellan Diagnostics blood lead test kits were undergoing a voluntary
recall by the manufacturer. FDA recommended that Magellan Diagnostics customers
discontinue using all affected test kit lots identified as part of the recall
and quarantine remaining inventory. On August 31, 2021, Magellan Diagnostics
began notifying customers that the recall was expanded to include additional
LeadCare II product lots. The recall now includes the majority of all test kits
distributed since October 27, 2020. Product distribution has been paused until
further notice, and replacement product is currently unavailable. It is unknown
when replacement product will be available.
Recommendations for Clinicians
Recommendations for Public Health
Professionals
For More
Information about Blood Lead Testing
For More
Information about the Recall
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More Information about Laboratory-related Resources
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