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 FDA has identified this as a Class I recall because of 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.
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.
Lots affected include:
- LeadCare II: 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M, and 2107M
- LeadCare Plus and LeadCare Ultra: 2011MU, 2104MU, and 2108MU
According to the FDA, laboratories or healthcare providers that currently have LeadCare II lots 2012M, 2018M, and 2102M in their inventory may continue to use these tests because Magellan has reported that they are not impacted by this recall. But they should report any failed quality control or suspect test results to Magellan Diagnostics.
Customers 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 mass spectrometry or graphite furnace atomic absorption spectrometry at a high complexity, CLIA-certified, reference laboratory.
- Promptly complete and return the Customer Notification Form in the Urgent Medical Device Recall. Complete this form even if you have no remaining inventory.
- After the form has been submitted, contact Magellan Technical Support to obtain a FedEx label to return any remaining inventory to Magellan and receive replacement product.
- Be aware, product will be replaced based on availability; replacement product is NOT currently available.
Health professionals and customers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.