FDA-Device2021-07-07Class I
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Magellan Diagnostics, Inc.
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.
Sold states
Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
Affected count
441 kits (192 tests/kit = 84,672 tests)
Manufactured in
101 Billerica Ave Bldg 4, N/A, North Billerica, MA, United States
Products
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1954-2021Don't want to check this manually?
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