ASP Global, LLC. dba Anatomy Supply Partners, LLC.: Device Recall

Recall #Z-0372-2026 · 05/05/2025

Class II: Risk

Recall Details

Recall Number: Z-0372-2026
Classification: Class II
Product Type: Device
Recalling Firm: ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Status: Ongoing
Date Initiated: 05/05/2025
Location: Austell, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,272,858

Reason for Recall

All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.

Product Description

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7053; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7056; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058 SAFE-T-FILL¿ End-to-End Capillary Tubes, 30 ¿L; Plastic, Prepared with EDTA Dipotassium Model: 06 0910

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI and the country of CA.

Other Recalls by ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Class II: Risk 09/26/2025

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II: Risk 09/26/2025

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II: Risk 09/26/2025

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II: Risk 09/26/2025

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Class II: Risk 09/26/2025

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

View all recalls by ASP Global, LLC. dba Anatomy Supply Partners, LLC. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.