LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Reported: July 7, 2021 Initiated: May 7, 2021 #Z-1953-2021
Product Description
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Reason for Recall
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.
Details
- Recalling Firm
- Magellan Diagnostics, Inc.
- Units Affected
- 320 kits (96 tests/kit=30,720 tests)
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
- Location
- North Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004. Recalled by Magellan Diagnostics, Inc.. Units affected: 320 kits (96 tests/kit=30,720 tests).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Critical. Recall number: Z-1953-2021.
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