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Recall Observatory FDA recall evidence

Device product

LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004

Z-1953-2021

May 07, 2021

Class I

Product summary

Firm
Magellan Diagnostics, Inc.
Event
Event 87992
Status
Terminated
Classification
Class I
Quantity
320 kits (96 tests/kit=30,720 tests)
Official record key
device-enforcement:Z-1953-2021

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.