Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Reported: May 24, 2017 Initiated: November 29, 2014 #Z-1926-2017
Product Description
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Reason for Recall
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Details
- Recalling Firm
- Magellan Diagnostics, Inc.
- Units Affected
- 1016
- Distribution
- Nationwide Distribution
- Location
- North Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010. Recalled by Magellan Diagnostics, Inc.. Units affected: 1016.
Why was this product recalled? ▼
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Critical. Recall number: Z-1926-2017.
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