Potential Shortage of Test Kits Following Recall


On March 30, 2022, Magellan Diagnostics resumed distribution of the LeadCare II product, which was previously unavailable. LeadCare Plus and LeadCare Ultra products are currently unavailable. More information is available at: https://www.fda.gov/medical-devices/medical-device-recalls/magellan-diagnostics-recalls-leadcare-ii-leadcare-plus-and-leadcare-ultra-blood-lead-tests-due-risk.external icon

On September 1, 2021, Magellan Diagnostics has expanded the voluntary recall of LeadCare Test Kits. More information is available at http://www.magellandx.com/uploads/2021/09/Magellan-Expanded-Recall-vFINAL.pdf. pdf icon[PDF – 132 KB]external icon

There are concerns about potential shortages of LeadCare® test kits used to analyze capillary blood lead samples from patients, following a recall on July 2, 2021. A shortage of LeadCare® test kits may result in fewer children receiving blood lead tests in their jurisdictions.

If LeadCare test kits are unavailable, CDC strongly recommends that healthcare providers not delay required blood lead testing for children. Blood lead testing can be done with either a venous or capillary blood sample, both of which can be submitted to a laboratory for analysis with higher complexity methods. Healthcare providers should contact laboratories for recommended blood collection supplies.

Public Health Considerations and Actions

Healthcare providers should continue to schedule and perform required blood lead tests for patients. A venous or capillary blood sample analyzed using higher complexity methods should be used if LeadCare® test kits are unavailable.

Public health professionals should work with healthcare providers in their jurisdictions to ensure patients receive their required blood lead tests. This outreach should include making providers aware of the need to conduct a capillary or venous test analyzed using higher complexity methods if LeadCare® test kits are unavailable.

By delaying blood lead testing for children due to the unavailability of LeadCare® test kits, children with higher blood lead levels risk not being identified and receiving necessary treatment and services.

If blood lead testing indicates blood lead levels above the current CDC Blood Level Reference Values (BLRV) and/or state or local action level, the healthcare provider or public health official should refer to CDC guidelines or state/local guidelines for appropriate follow-up action.

LeadCare devices should be used according to U.S. Food and Drug Administration (FDA) approvals. Currently, venous samples are not approved by the FDA to be analyzed with LeadCare devices.

Background Information

The FDA issued a recall notice for LeadCare® test kits because certain LeadCare II, LeadCare Plus, and LeadCare Ultra test kit lots were producing falsely low results. Customers are directed to discontinue use of all test kit lots identified as part of the recall and quarantine remaining inventory.

LeadCare® test kits are used to measure a person’s blood lead level using a capillary sample. After the sample is mixed with treatment reagent, a LeadCare® analyzer measures the amount of lead collected on a sensor.

Clinicians may use a capillary test or a venous blood draw to determine a child’s blood lead level.

  • finger-prick, or capillary, test is usually the first step to determine if a child has lead in their blood. If the child had a blood lead level above CDC’s blood lead reference value (BLRV), a second test is done to confirm.
  • venous blood draw takes blood from a child’s vein. This type of test can take a few days to receive results and is often used to confirm if the child has a blood lead level above the BLRV as seen in the first capillary test.

Both capillary and venous samples can be analyzed using higher complexity methods such as such as inductively coupled plasma mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectroscopy (GFAAS). However, venous samples are more reliable at identifying lower blood lead levels than capillary samples when analyzed using higher complexity methods (i.e., ICP-MS and GFAAS).

For more information, refer to Blood Lead Levels in Children.