medical Class I Updated 2021-07-07

Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit Catalog Number 70-6762

Recalled Product

LeadCare II Blood Lead Test Kit Catalog Number 70-6762


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: 2013M - 22APR22; 2014M - 29APR22; 2015M - 12MAY22; 2016M - 19MAY22; 2017M - 10JUN22; 1st expansion 6/21/2021: 2101M - 28JUL22; 2103M - 18AUG22; 2105M - 11SEP22; 2106M - 21JAN22; 2107M - 30SEP22; 2nd expansion 8/30/2021; 2012M Sublots: -08, -09, -10, -11, -12, -13, -14 - 08APR22; 2018M - 06JUN22; 2102M - 30SEP21; 2109M - 15OCT22; 2110M - 29OCT22; 2111M - 31MAY22; 2112M - 13NOV22; 2113M - 30JUN22; 2114M - 17DEC22; 2115M - 29DEC22; 7114M - 17DEC22.
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