NEW YORK – Meridian Bioscience announced on Wednesday that its subsidiary Magellan Diagnostics has expanded its Class I recall of multiple LeadCare products for blood lead testing.
The recall includes certain lots of LeadCare II Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits. The products are used to detect lead in whole blood.
Magellan began the recall in May after finding an ongoing issue with the testing of the controls in the kits. Two controls that are provided in the test kits are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range. Results from the controls within that acceptable range show the system is working properly.
The firm received reports that control tests of the "low-control" and the "high-control" generated a "low" result, meaning the LeadCare kits could underestimate blood lead levels when processing patient blood samples, Meridian said in a statement.
Product distribution has been paused and a replacement product isn't currently available, the Cincinnati-based company added.
Magellan has recommended customers discontinue use of the affected LeadCare lots and quarantine remaining inventory, while distributors should stop distribution of the recalled lots. It also recommended healthcare providers recheck test results generated with the recalled kits and confirm results with an alternative lead testing option.