ClearanceBrief
Recall Z-0372-2026 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

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

DateOct 27, 2025 (initiated May 5, 2025)
StatusOpen, Classified
ReasonAll 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.
Root causeComponent design/selection
ActionStarting on 5//5/2025 customers were informed that there had been reports of falsely elevated blood lead levels associated with the use of affected micro capillary tubes for lead testing when used with Magellan LeadCare Testing Systems. On 9/8/2025, recall notices were emailed to customers who were asked to do the following: Discontinue use of the recalled products immediately. b) Quarantine any remaining inventory to prevent further use. c) Dispose remaining inventory in accordance with local regulations or notify firm at FieldActions@aspglobal.com for return authorization and disposal assi
Quantity4,272,858
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K981973SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Ram Scientific, Sep 3, 1998