FDA-Device2025-11-05Class II
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,
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Hazard
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.
Sold states
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.
Affected count
4,272,858
Manufactured in
7800 Third Flag Pkwy, N/A, Austell, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0372-2026Don't want to check this manually?
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