Date Issued: April 24, 2025
The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. These tests may overestimate blood lead levels and give inaccurate results when processing capillary blood samples collected in these ASP Global’s RAM Scientific SAFE-T-FILL tubes. The root cause of these false results is not yet known. The FDA is recommending that ASP Global RAM Scientific SAFE-T-FILL tubes not be used with the LeadCare Testing Systems while this issue is being investigated.
False test results may delay an accurate diagnosis and may lead to improper patient management and unnecessary follow-up tests (with additional risks), increased stress for patients and families, and disruptions in care. Timely and accurate detection of elevated lead levels is essential to prevent the harmful effects of lead poisoning and ensure patients receive the right care without delay.
The FDA is issuing this communication along with the following recommendations to mitigate the potential risk of inaccurate test results to assure that patients receive accurate information regarding potential lead exposure.
Recommendations for Health Care Providers and Facilities, Laboratory Staff, and Patients and Caregivers
- Avoid using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
- The capillary collection devices that are provided with the LeadCare Test Systems as well as other third-party capillary blood collection tubes, as described in the instructions for use of LeadCare Testing Systems, can still be used.
- If no alternate capillary blood collection devices are available other than the ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes, interpret results with caution and consider retesting with a different method or specimen type.
- Follow CDC’s recommendations for confirmatory venous blood testing based on blood lead levels observed in capillary blood lead tests (https://www.cdc.gov/lead-prevention/testing/index.html).
Device Description
The LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests are used to detect lead in a blood sample, which may be obtained from finger or heel prick (capillary). The current reports of inaccurate results are only with capillary samples collected in ASP Global RAM Scientific SAFE-T-FILL tubes. The LeadCare Testing Systems are used in clinical laboratories, doctor’s offices, clinics, and hospitals throughout the U.S. The LeadCare Test Kit includes capillary collection devices for use with the test system, and there have not been reports of falsely elevated results with the provided collection devices at this time. Sometimes third-party capillary blood collection tubes, sold separately, are also used for these tests. At this time, falsely elevated results have only been reported when ASP Global RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection devices are used with the LeadCare Test Systems.
FDA Actions (Updated May 27, 2025)
The FDA is investigating the root cause of this issue with the manufacturers of the tests and collection tubes and will provide updates as critical information becomes available.
While the investigation is ongoing into the root cause of the false positive results discussed in this safety communication, on May 9, 2025, the FDA issued a Warning Letter to Kabe Labortechnik GmbH, the manufacturer of blood collection tubes, including the SAFE-T-FILL Capillary Blood Collection Systems distributed by ASP Global and referenced in this safety communication. This action follows an inspection by FDA of Kabe Labortechnik GmbH that revealed significant Quality System Regulation (QSR) and Medical Device Reporting (MDR) violations. As discussed in the Warning Letter, the FDA has taken steps to refuse entry of any devices manufactured by Kabe Labortechnik GmbH into the United States, referred to as an import alert, until these violations are addressed.
The FDA will keep the public informed if significant new information becomes available.
Related Warning Letters
Timeline of FDA Communication Updates
| Date | Actions |
| 05/27/2025 | The FDA updated this communication to announce a warning letter was issued to Kabe Labortechnik GmbH for significant Quality System Regulation and Medical Device Reporting violations. As a result, the FDA initiated an import alert to prevent blood collection tubes manufactured by Kabe Labortechnik GmbH from entering the United States. |
| 04/25/2025 | The FDA issued this communication to alert health care providers and laboratory staff of reports of falsely elevated results occurring when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. |
Reporting Problems with Your Device
Health professionals and patients are encouraged to report adverse events or side effects related to the use of ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes, Magellan Diagnostics LeadCare Testing Systems, or other devices to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices. The FDA regularly monitors the post-authorization use of tests, including reports of problems with test performance or results.
Questions?
If you have questions, contact CDRH's Division of Industry and Consumer Education (DICE).
