Wisconsin DHS Health Alert
Expanded Recall of LeadCare® Blood Lead Test Kits
Bureau of Environmental and Occupational Health
September 24, 2021
Key Points:
- Magellan Diagnostics, Inc. has expanded their product recall of LeadCare II Blood Lead Test Kits. These test kits may give falsely low results.
- Because the recall affects nearly all LeadCare II test kits in circulation, providers should immediately discontinue use of all kits and quarantine remaining inventory.
- Retest children who were tested with recalled test kits whose results were <5mcg/dL. Re-testing should be performed using higher complexity testing at a CLIA-certified reference laboratory. This can include collecting capillary samples and sending them to a lab for testing.
- Retest children who were previously tested using LeadCare test kits if the lot number is unknown and the test was performed after October 27, 2020. Priority should be given to children with symptoms of lead poisoning, those at higher risk of lead exposure, and persons who are pregnant or breastfeeding.
- LeadCare analyzers are not impacted by the recall.
- Magellan Diagnostics has temporarily stopped shipments of LeadCare test kits and has not issued a definitive date to resume shipments.
- Further information can be found on this DHS webpage and in this Meridian Bioscience, Inc. news release.
Dear colleagues,
On September 1, 2021, Magellan Diagnostics, Inc. expanded a recall regarding the point-of-care LeadCare II, LeadCare Plus, and LeadCare Ultra test kits. These test kits may give falsely low results. Providers can refer to the previously issued retesting recommendations from CDC’s July Health Advisory. Magellan has stopped shipments of LeadCare test kits and has not yet set a definitive date to resume shipments. Magellan continues to investigate the root cause of the COOR-LO failure mode and is working diligently to find a solution to resume shipments/replacements as quickly as possible. If you have questions about this recall, please contact Magellan’s LeadCare Product Support Team at 1-800-275-0102, or email leadcaresupport@magellandx.com.
The expanded recall includes LeadCare® II Blood Test Kit lots: 2012M (Sublots -08, -09, -10, -11, -12, -13, and -14); 2018M; 2102M; 2109M; 2110M; 2111M; 2112M; 2113M; 2114M; and 2115M. These lots are in addition to previously recalled lots.
Jonathan Meiman, MD
Chief Medical Officer and State Epidemiologist for Environmental and Occupational Health
Wisconsin Department of Health Services
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