Magellan Diagnostics, Inc.: Lead, Atomic Absorption
LeadCare Plus Blood Lead Test Kit Recall Summary Magellan Diagnostics is recalling the LeadCare Plus Blood Lead Test Kit (Catalog Number 82-0004) because certain third-party blood collection devices used with this kit are producing falsely elevated lead results. These false positive results may lead to unnecessary additional testing and delayed accurate results. The recall affects kits distributed nationwide in the U.S. and in numerous countries worldwide.
- Recalling firm
- Magellan Diagnostics, Inc.
- Product
- LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
- Reason
- Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-13
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan, Bolivia, Canada, Chile, Diego Garcia, Ecuador, Eritrea, Georgia, Ghana, Guam, Guatemala, Haiti, Hong Kong, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kyrgyzstan, Mexico, Nepal, Peru, Philippines, South Africa,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ddc721b4-b5f1-4a43-8a79-74b2370b27f7