The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries.

Recalled Product

• LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests
• Lot codes:  Refer to the Medical Device Recalls database entry for each product.
  • LeadCare II
  • LeadCare Plus
  • LeadCare Ultra
• Manufacturing Dates: October 26, 2020 to August 12, 2021
• Distribution Dates: October 27, 2020 to August 19, 2021
• Date Initiated by Firm: May 28, 2021

Device Use

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.

Reason for Recall

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 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. 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.

Who May Be Affected

• Health care providers and laboratories who may have access to these tests
• People who were tested using these devices

What to Do

On May 28, 2021, Magellan notified distributors through phone calls and on June 7, 2021 sent customers an Urgent Medical Device Recall letter requesting product removal of specific lots. On June 23, 2021, Magellan notified customers by phone the recall has been expanded to include additional lots. On August 31, 2021, Magellan began notifying customers by email and distributors by phone that 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.

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

Customers:

• 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.
• Refer to retesting recommendations from the CDC
• Promptly complete and return the Customer Notification Form in the Urgent Medical Device Recall letter to [email protected] or FAX to (978) 600-1480 (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory.
• After the form has been submitted, contact Magellan Technical Support 1-800-275-0102 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. Magellan Diagnostics has resumed distribution of the LeadCare II product, which was previously unavailable. LeadCare Plus and LeadCare Ultra products are currently unavailable.

Distributors:

• Stop distribution of LeadCare blood lead test kits identified as part of the recall; review current inventory and quarantine any remaining stock.
• Promptly complete and return the Customer Notification Form provided in the Urgent Medical Device Recall to [email protected] or FAX to (978) 600-1480 (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory.
• After the form has been submitted, contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan and receive replacement product.
• Be aware, the product will be replaced based on availability. Magellan Diagnostics has resumed distribution of the LeadCare II product, which was previously unavailable. LeadCare Plus and LeadCare Ultra products are currently unavailable.
• Provide to Magellan a distribution list of customers that have received the impacted product.

Contact Information

Customers with questions about this recall should contact Magellan's LeadCare Product Support Team at 1-800-275-0102, or email at [email protected].

Additional Resources

• CDC issued a Lab Alert: Magellan Diagnostics Recalls Several LeadCare® Blood Lead Tests Due to Risk of Falsely Low Results
• Press Release: Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits (PDF-132KB)

How Do I Report a Problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.