medical Class I Updated 2021-07-07

Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Recalled Product

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098


Hazard / Issue

Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.
View official government recall

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