Magellan Diagnostics is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood lead tests due to a significant risk of falsely low results. The Food and Drug Administration (FDA) has designated this as a Class I recall, the most serious type.

The LeadCare II, LeadCare Plus, and LeadCare Ultra Blood lead tests use a finger or heel stick whole blood sample to determine an individual’s blood lead level. The LeadCare systems are used in clinical laboratories, physician’s offices, clinics, and hospitals in the US. 

The FDA is concerned that obtaining falsely low test results may lead to inappropriate follow-up assessments, which may result in patient harm. The recalled products were distributed between October 27, 2020 and June 15, 2021 and include the following lot codes:

  • LeadCare II: 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M, and 2107M.
  • LeadCare Plus and LeadCare Ultra: 2011MU, 2104MU, and 2108MU.

At this time, the Company reports that the following 3 lots of LeadCare II test kits are not impacted by this recall: 2012M, 2018M, and 2102M.


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It is recommended that use of all affected test kit lots be discontinued and any test results that are unclear should be confirmed with an alternative lead testing option. Children who were tested with the recalled LeadCare test kits whose results were less than 5µg/dL should be retested with a venous blood sample analyzed with higher complexity testing. Children should also be retested if they were tested with a LeadCare test kit with an unknown lot number between October 27, 2020 and July 6, 2021.

According to the Centers for Disease Control and Prevention, priority for retesting should be given to (1) children where there is clinical concern that symptoms or developmental problems may be related to lead exposure; (2) populations at higher risk of elevated blood lead levels, such as children tested due to Medicaid-required screening or due to other state or local requirements; and (3) individuals who are pregnant or breastfeeding.

Adverse events related to this recall should be reported to the FDA’s MedWatch Program. More information about the recall can be obtained by calling (800) 275-0102 or emailing [email protected].

References

  1. Recall of LeadCare® Blood Lead Tests due to risk of falsely low results. US Centers for Disease Control and Prevention. Accessed July 6, 2021. https://emergency.cdc.gov/han/2021/han00445.asp?ACSTrackingID=USCDC_511-DM60951&ACSTrackingLabel=HAN%20445%20-%20General%20Public&deliveryName=USCDC_511-DM60951
  2. Magellan Diagnostics recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to risk of falsely low results. [press release]. Silver Spring, MD: US Food and Drug Administration; July 1, 2021.