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Recall Observatory FDA recall evidence

Device product

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Z-1954-2021

May 07, 2021

Class I

Product summary

Firm
Magellan Diagnostics, Inc.
Event
Event 87992
Status
Terminated
Classification
Class I
Quantity
441 kits (192 tests/kit = 84,672 tests)
Official record key
device-enforcement:Z-1954-2021

Official wording

Reason: 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.

Code information: Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.

Distribution pattern: Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.