Agency issues warning letters to manufacturers after reports of falsely elevated results when using ASP Global’s RAM Scientific SAFE-T-FILL tubes with LeadCare Testing Systems.
The US Food and Drug Administration (FDA) is warning healthcare providers and laboratory staff about reports of falsely elevated lead test results when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with Magellan Diagnostics LeadCare Testing Systems.
The agency issued the initial safety communication in April 2025 after receiving reports that the combination may overestimate blood lead levels and produce inaccurate results when processing capillary blood samples. The root cause of these false results remains unknown, and the FDA recommends against using ASP Global RAM Scientific SAFE-T-FILL tubes with LeadCare Testing Systems while the investigation continues.
False test results may delay accurate diagnosis and lead to improper patient management, unnecessary follow-up tests, increased stress for patients and families, and disruptions in care, according to the FDA.
Multiple Warning Letters Issued
The FDA has escalated its response by issuing warning letters to three companies involved in manufacturing and distributing the affected devices.
In December 2025, the agency issued a warning letter to Meridian Bioscience Inc, owner of Magellan Diagnostics Inc, which manufactures the LeadCare II Blood Lead Analyzer and Test Kit. The action followed an FDA inspection that identified significant Quality System Regulation, Medical Device Reporting, and Corrections and Removals violations.
The FDA also issued a warning letter to ASP Global LLC in December 2025, citing violations found during inspection of the domestic company responsible for manufacturing and US distribution of RAM Scientific SAFE-T-FILL Capillary Collection System tubes.
Earlier, in May 2025, the FDA issued a warning letter to Kabe Labortechnik GmbH, the German manufacturer of the blood collection tubes distributed by ASP Global. The agency has implemented an import alert to refuse entry of any devices manufactured by Kabe Labortechnik GmbH into the US until violations are addressed.
Affected Testing Systems
The LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests detect lead in blood samples obtained from finger or heel prick. These point-of-care systems are used in clinical laboratories, physician offices, clinics, and hospitals throughout the US.
Current reports of inaccurate results involve only capillary samples collected in ASP Global RAM Scientific SAFE-T-FILL tubes. The LeadCare Test Kit includes capillary collection devices for use with the test system, and no falsely elevated results have been reported with the provided collection devices.
The FDA continues investigating the root cause with manufacturers and will provide updates as information becomes available. Healthcare professionals and patients are encouraged to report adverse events related to these devices through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Timely and accurate detection of elevated lead levels is essential to prevent harmful effects of lead poisoning and ensure patients receive appropriate care without delay, according to the agency.
ID 168295121 © Francesco Scatena | Dreamstime.com
