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Magellan provides two controls in the test kits 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 received reports that control tests of either the "Low-Control" and/or the "High-Control" generated a "low" result.
Impacted LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples.
Related content: Benzinga's Full FDA Calendar.
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