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Magellan Diagnostics, Inc. Recall: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-80

Magellan Diagnostics, Inc. Recall: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-80 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Magellan Diagnostics, Inc.; Product: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098; Reason for recall: Magellan has received reports th

Recalling firmMagellan Diagnostics, Inc.
ProductLeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Reason for recallMagellan 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.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionWorldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
Recall initiated20210507
Recall numberZ-1954-2021
Categorydevice
StateMA
CountryUnited States

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