FDAFDA · Food and drugs·Recall number Z-1954-2021
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Published July 7, 2021 · Recall initiated: May 7, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Magellan Diagnostics, Inc.
- Distributor
- Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
- Lot
- Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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