FDA Class I Recall: Magellan Diagnostics LeadCare II, LeadCare Plus, and LeadCare Ultra Blood lead tests

Sept. 29, 2021

Magellan Diagnostics, Inc., is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results. The U.S. Food & Drug Administration (FDA) has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such as young children and pregnant individuals. The FDA has classified this as a Class I Recall.

A pregnant or lactating individual's exposure to lead is concerning because it not only may cause health problems for the parent but can result in lead exposure to the developing baby. Obtaining falsely low results may lead to patient harm including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children. 

The recall was expanded a second time to include the following LeadCare II lots of test kits, which includes lots previously reported as unaffected by this recall: sublots 2012M-08, 2012M-09, 2012M-10, 2012M-11, 2012M-12, 2012M-13, and 2012M-14; and full lots 2018M; 2102M; 2109M; 2110M; 2111M; 2112M; 2113M; 2114M; 2115M; and 7114M. 

The LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests are used to find out a person's blood lead level. The test uses a finger or heel stick whole blood (capillary) sample. After the sample is mixed with treatment reagent, a LeadCare analyzer measures the amount of lead collected on a sensor. 

Magellan's LeadCare II is a point-of-care (CLIA-waived) blood lead testing system. The LeadCare systems are used in clinical laboratories, doctor's offices, clinics, and hospitals throughout the United States. 

Customers and distributors are instructed to also take the following actions: 

  • Discontinue use of all test kit lots identified as part of the recall and quarantine remaining inventory. 
  • Laboratories should evaluate patient test results that were generated with the impacted lots. 
  • Confirm suspect results with an alternative lead testing option, such as those using inductively coupled plasma mass spectrometry or graphite furnace atomic absorption spectroscopy at a high complexity, CLIA-certified, reference laboratory. 
  • Be aware, the product will be replaced based on availability; replacement product is NOT currently available.  

 FDA Recall release