FDA Class I Recall: LeadCare Test Kits from Magellan Diagnostics, Inc.

Sept. 7, 2021

Meridian Bioscience, Inc., a provider of diagnostic testing solutions and life science raw materials, announced its wholly owned subsidiary, Magellan Diagnostics expanded the Class I recall of its LeadCare II Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits for the detection of lead in whole blood according to a release from The U.S. Food and Drug Administration (FDA).

Magellan provides two controls in the test kits which are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range. Results of the control tests within the acceptable range indicate that the system is operating properly before testing patient samples. In May 2021, Magellan initiated this voluntary recall after identifying an ongoing issue with testing of the controls included in the LeadCare Test Kits. Magellan continues to investigate this issue and has conducted extensive testing to evaluate potential root causes. 

Magellan received reports that control tests of either the “Low-Control” (e.g., the “Level 1” control at approximately 9 g/dL ± 3g/dL) and/or the “High-Control” (e.g., the “Level 2” control at approximately 28 g/dL ± 4g/dL) generated a “low” result (i.e., “Control Out of Range-Low” [“COOR-L”]). Magellan initiated the recall because the impacted LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples.

As part of the recall to the user level, Magellan is notifying customers and distributors affected by the recall.  Magellan's customer recall notification provides instructions for the return and replacement of the impacted LeadCare Test Kits.

Magellan recommends the following:

  • Customers should discontinue use of all LeadCare Test Kits lots identified as part of the recall and quarantine remaining inventory.
  • Distributors should stop distribution of all LeadCare Test Kits lots identified as part of the recall, review current inventory and quarantine any remaining stock.
  • Health Care Providers should evaluate patient test results that were generated with all recalled lots.
  • Suspect results should be confirmed with an alternative lead testing option, such as those using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) at a high complexity, CLIA-certified, reference laboratory.

The complete list of kits is included in the FDA release