Risk Of False Positive Lead Test Results With Certain Capillary Blood Collection Tubes Used With Magellan Diagnostics Leadcare Testing Systems – FDA Safety Communication
Recall Summary Certain Micro Capillary Blood Collection tubes used with Magellan Diagnostics LeadCare Testing Systems may produce false positive results for lead levels in blood tests. The FDA is notifying healthcare providers and lab staff about this issue so they can identify potentially inaccurate test results. This affects patients who have been tested for lead exposure using these specific tubes and testing systems.
- Product
- FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
- Reason
- FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-02-03
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/2ea75cca-b69d-4bac-882e-c4e5b6111ae1