Benzinga | Sep 2, 2021 07:58AM EDT

Meridian Bioscience Expands Voluntary Recall of LeadCare Test Kits

* 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.