Magellan Diagnostics is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood electrode tests due to a significant risk of false low results. The Food and Drug Administration (FDA) has classified this as the class that I remember being the most serious type.
The LeadCare II, LeadCare Plus, and LeadCare Ultra Blood lead tests use a sample of whole blood from a finger or heel to determine a person’s blood lead level. The LeadCare systems are used in clinical laboratories, doctor’s offices, clinics and hospitals in the USA.
The FDA fears that receiving falsely low test results could lead to inadequate follow-up examinations that could harm patients. The recalled products were distributed between October 27, 2020 and June 15, 2021 and contain the following batch codes:
- LeadCare II: 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M, and 2107M.
- LeadCare Plus and LeadCare Ultra: 2011MU, 2104MU and 2108MU.
Currently, the company reports that the following 3 lots of LeadCare II test kits are not affected by this recall: 2012M, 2018M, and 2102M.
It is recommended that you discontinue use of all affected test kit lots and confirm unclear test results with an alternative lead test option. Children tested with the recalled LeadCare test kits with results less than 5 µg / dL should be retested with a venous blood sample that has been analyzed with more complex tests. Children should also be retested if 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 should be given to retesting (1) children who have clinical concerns that symptoms or developmental problems may be related to lead exposure; (2) Populations at greater risk for elevated blood lead levels, such as children tested based on Medicaid-mandated screening or other state or local requirements; and (3) people who are pregnant or breastfeeding.
Adverse events related to this recall should be reported to the FDA’s MedWatch program. For more information about the callback, please call (800) 275-0102 or email LeadCareSupport@magellandx.com.
- Recall of LeadCare® Blood Lead Tests because of the risk of false 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.
- Magellan Diagnostics is recalling LeadCare II, LeadCare Plus, and LeadCare Ultra blood electrode tests because of the risk of false low results. [press release]. Silver Spring, MD: US Food and Drug Administration; July 1, 2021.
This article originally appeared on MPR