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Meridian Bioscience Expands Voluntary Recall of LeadCare Test Kits

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  • Meridian Bioscience Inc's (NASDAQ: VIVO) subsidiary Magellan Diagnostics Inc has expanded the Class I recall of its LeadCare Test Kits used to detect lead in whole blood.

  • 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.

  • Price Action: VIVO stock closed 1.73% higher at $20.59 on Wednesday.

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