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Magellan Diagnostics, Inc. Recall 87992

Description: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

Magellan Diagnostics, Inc. Recall 87992 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1954-2021
Event ID87992
Event DescriptionLeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Product TypeDevices
DistributionWorldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
Quantity441 kits (192 tests/kit = 84,672 tests)
Recall ReasonMagellan 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.
Device Classification20210707
Device Code InfoLot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.
Center Classification Date20210701
Recall Initiation Date20210507
Recalling FirmMagellan Diagnostics, Inc.
Initial Notification Letter
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