Lead Care Test Kit Recall - July 2021

What is the recall for?

Magellan Diagnostics, Inc and the U.S. Food and Drug Administration (FDA) issued a recall notice for LeadCare test kits distributed between October 27, 2020 and June 15, 2021.

Why is there a recall?

The use of these test kits can cause serious injuries as they might underestimate blood lead levels. The U.S. FDA has identified this recall as a Class I recall, the most serious type of recall.

Am I affected in this recall?

Magellan Diagnostics, Inc and the FDA have released information on the products affected by the recall. Please visit the FDA’s page for the latest information.

As of September 1st, 2021, Magellan Diagnostics has released an extended recall notice. Please view this list of affected test kits to see if your device is listed.

What should I do with my device?

Please follow the recommendations and guidance from the U.S. FDA
Please follow the guidance and recommendation from the Centers for Disease Control and Prevention (CDC).

Do I have to retest children who were tested with the recalled test kits?

Per the CDC, it is recommended to retest children who were tested with recalled LeadCare test kits whose results were less than 5 µg/dL. Retesting should be done with a venous blood sample and analyzed by higher complexity testing. Higher complexity testing can include inductively coupled plasma mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectroscopy (GFAAS). These tests are generally more accurate for testing blood lead levels.

You can learn more about what types of testing should be done on the CDC’s Health Alert page.

Is there another way to test children until the recall is over?

Providers can still test for blood lead. Providers can either take a capillary or a venous blood draw to test for lead and send samples to a laboratory of their choice. 

If a provider participates in the Texas Health Steps program, they are eligible to send samples to the Texas Department of State Health Services Laboratory at no extra charge.

What if I don’t have access to extra Lead Care II test kits

The CDC recommends providers not delay required blood lead testing for children. Alternative methods of testing can be through venous or capillary blood samples. For more information, please visit the CDC’s notice test kit availability.

How can I report?

Providers are encouraged to keep reporting all blood lead test results. Providers have the option of using the electronic submission form sent to them courtesy of BLSB, or fax results to (512) 776-7699 using the appropriate form. Click here for a copy of the fax form.

Please let us know if you have any questions by emailing us at TexasBloodLead@dshs.texas.gov or calling us at (512) 776-7151.

Last updated September 14, 2021