FDAFDA · Food and drugs·Recall number Z-1296-2018
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Published April 11, 2018 · Recall initiated: January 9, 2018
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
The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Magellan Diagnostics, Inc.
- Distributor
- Worldwide Distribution
- Lot
- Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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