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Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Recalled July 7, 2021 · FDA recall Z-1952-2021 · Magellan Diagnostics
Hazard
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. · FDA Class I
Units
387,281 kits (48 tests/kit=1,757,040 tests)
Sold at
Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
Description
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.
Product
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Manufacturer(s)
Magellan Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →